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Critical RiskFDA Device

Heartware, Inc.: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Agency Publication Date: May 22, 2020
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Affected Products

Product: Heartware HVAD Pump Implant Kit, Product (REF) Number 1103

GTIN 00888707000017, Serial Numbers: HW26899, HW27283, HW27893, HW28873, HW28999, HW29422, HW29488, HW29722, HW30166, HW30170 GTIN 00888707002639, Serial Numbers: HW29525, HW30015, HW30297, HW30477, HW31174, HW31179, HW31181, HW31246, HW31247, HW31250, HW31253, HW31257, HW31266, HW31268, hw31280, HW31281, hw31282, HW31283, HW31313, HW31385, HW31401, HW31497, HW31525, HW31526, HW31530, HW31531, HW31562, HW31567, HW31596, HW31597, HW31601, HW31602, HW31608, HW31609, HW31612, HW31624, HW31626, HW31634, HW31640, HW31641, HW31642, HW31643, HW31644, HW31645, HW31646, HW31647, HW31648, HW31649, HW31651, HW31652, HW31653, HW31655, HW31656, HW31657, HW31658, HW31659, HW31660, HW31661, HW31662, HW31663, HW31665, HW31666, HW31667, HW31668, HW31669, HW31670, HW31671, HW31672, HW31674, HW31675, HW31676, HW31677, HW31678, HW31679, HW31680, HW31681, HW31682, HW31687, HW31688, HW31689, HW31690, HW31691, HW31692, HW31693, HW31695, HW31696, HW31701, HW31705, HW31706, HW31707, HW31708, HW31709, HW31710, HW31711, HW31712, HW31713, HW31714, HW31716, HW31717, HW31719, HW31720, HW31721, HW31722, HW31723, HW31724, HW31725, HW31726, HW31728, HW31730, HW31732, HW31734, HW31736, HW31737, HW31738, HW31739, HW31740, HW31741, HW31742, HW31743, HW31744, HW31745, HW31746, HW31747, HW31748, HW31751, HW31752, HW31753, HW31754, HW31756, HW31757, HW31758, HW31760, HW31761, HW31762, HW31763, HW31764, HW31765, HW31766, HW31767, HW31768, HW31769, HW31770, HW31771, HW31772, HW31773, HW31774, HW31775, HW31776, HW31781, HW31782, HW31783, HW31784, HW31785, HW31786, HW31787, HW31788, HW31789, HW31790, HW31792, HW31793, HW31794, HW31796, HW31797, HW31798, HW31799, HW31800, HW31802, HW31803, HW31804, HW31805, HW31807, HW31816, HW31829, HW31841, HW31848, HW31850, HW31853, HW31854, HW31857, HW31861, HW31862, HW31864, HW31865, HW31866, HW31867, HW31868, HW31869, HW31870, HW31871, HW31878, HW31879, HW31880, HW31881, HW31882, HW31884, HW31885, HW31886, HW31887, HW31888, HW31889, HW31890, HW31894, HW31895, HW31896, HW31897, HW31898, HW31899, HW31900, HW31902, HW31904, HW31905, HW31906, HW31907, HW31910, HW31911, HW31913, HW31914, HW31916, HW31917, HW31918, HW31922, HW31923, HW31933, HW31935, HW31936, HW31938, HW31942, HW31943, HW31945, HW31946, HW31948, HW31949, HW31950, HW31951, HW31952, HW31953, HW31954, HW31956, HW31957, HW31959, HW31960, HW31961, HW31962, HW31963, HW31964, HW31965, HW31966, HW31967, HW31968, HW31969, HW31970, HW31971, HW31972, HW31974, HW31975, HW31977, HW31978, HW31980, HW31990, HW32003, HW32004, HW32005, HW32007, HW32016, HW32019, HW32020, HW32031, HW32033, HW32037, HW32041, HW32044, HW32045, HW32047, HW32048, HW32049, HW32051, HW32052, HW32054, HW32058, HW32059, HW32060, HW32061, HW32063, HW32066, HW32067, HW32069, HW32070, HW32072, HW32073, HW32074, HW32075, HW32076, HW32077, HW32078, HW32079, HW32080, HW32082, HW32083, HW32084, HW32087, HW32088, HW32089, HW32090, HW32091, HW32092, HW32093, HW32095, HW32096, HW32097, HW32098, HW32099, HW32100, HW32101, HW32104, HW32105, HW32106, HW32107, HW32110, HW32111, HW32114, HW32115, HW32117, HW32119, HW32120, HW32122, HW32126, HW32127, HW32128, HW32129, HW32130, HW32133, HW32134, HW32136, HW32137, HW32139, HW32140, HW32142, HW32145, HW32146, HW32148, HW32150, HW32151, HW32154, HW32155, HW32157, HW32158, HW32168, HW32169, HW32171, HW32173, HW32174, HW32176, HW32177, HW32178, HW32184, HW32185, HW32187, HW32188, HW32191, HW32196, HW32203, HW32208, HW32213, HW32225, HW32227, HW32233, HW32235, HW32237, HW32247, HW32249, HW32251, HW32252, HW32254, HW32262, HW32266, HW32267, HW32271, HW32272, HW32274, HW32275, HW32276, HW32277, HW32278, HW32280, HW32283, HW32284, HW32287, HW32288, HW32291, HW32293, HW32295, HW32296, HW32298, HW32299, HW32300, HW32302, HW32303, HW32304, HW32305, HW32306, HW32307, HW32308, HW32310, HW32311, HW32312, HW32313, HW32314, HW32316, HW32317, HW32318, HW32319, HW32320, HW32321, HW32322, HW32323, HW32324, HW32325, HW32326, HW32327, HW32328, HW32329, HW32330, HW32331, HW32332, HW32333, HW32334, HW32337, HW32338, HW32339, HW32340, HW32341, HW32343, HW32344, HW32345, HW32346, HW32348, HW32349, HW32350, HW32351, HW32352, HW32354, HW32355, HW32358, HW32359, HW32360, HW32361, HW32362, HW32363, HW32364, HW32365, HW32366, HW32367, HW32368, HW32370, HW32371, HW32372, HW32374, HW32375, HW32376, HW32377, HW32378, HW32379, HW32380, HW32381, HW32382, HW32383, HW32384, HW32387, HW32389, HW32390, HW32391, HW32392, HW32395, HW32396, HW32397, HW32398, HW32399, HW32401, HW32402, HW32403, HW32404, HW32405, HW32406, HW32409, HW32411, HW32412, HW32413, HW32414, HW32417, HW32418, HW32421, HW32422, HW32424, HW32425, HW32428, HW32429, HW32430, HW32431, HW32432, HW32433, HW32434, HW32436, HW32438, HW32439, HW32440, HW32441, HW32442, HW32443, HW32444, HW32446, HW32447, HW32448, HW32449, HW32450, HW32451, HW32452, HW32453, HW32454, HW32455, HW32456, HW32460, HW32461, HW32462, HW32463, HW32466, HW32467, HW32469, HW32475, HW32476, HW32477, HW32478, HW32480, HW32481, HW32482, HW32484, HW32485, HW32486, HW32487, HW32488, HW32489, HW32490, HW32491, HW32492, HW32493, HW32494, HW32495, HW32496, HW32497, HW32498, HW32500, HW32501, HW32502, HW32503, HW32512, HW32526, HW32527, HW32528, HW32529, HW32530, HW32531, HW32532, HW32533, HW32535, HW32536, HW32537, HW32538, HW32539, HW32540, HW32541, HW32542, HW32543, HW32544, HW32545, HW32547, HW32549, HW32550, HW32551, HW32552, HW32553, HW32555, HW32556, HW34011, HW34013, HW34014, HW34016, HW34032, HW34055, HW34057, HW34058, HW34059, HW34061, HW34063, HW34064, HW34065, HW34067, HW34070, HW34071, HW34073, HW34074, HW34076, HW34077, HW34079, HW34080, HW34081, HW34082, HW34083, HW34085, HW34087, HW34089, HW34097, HW34098, HW34099, HW34101, HW34102, HW34103, HW34105, HW34108, HW34112, HW34114, HW34116, HW34118, HW34119, HW34127, HW34128, HW34130, HW34131, HW34133, HW34134, HW34135, HW34136, HW34137, HW34138, HW34139, HW34140, HW34141, HW34142, HW34143, HW34144, HW34145, HW34146, HW34147, HW34153, HW34154, HW34155, HW34156, HW34157, HW34158, HW34159, HW34160, HW34162, HW34163, HW34164, HW34165, HW34166, HW34167, HW34168, HW34170, HW34171, HW34172, HW34173, HW34174, HW34175, HW34176, HW34177, HW34178, HW34183, HW34185, HW34188, HW34189, HW34190, HW34194, HW34195, HW34198, HW34199, HW34200, HW34201, HW34203, HW34212, HW34213, HW34214, HW34215, HW34216, HW34217, HW34218, HW34219, HW34220, HW34221, HW34222, HW34223, HW34224, HW34225, HW34227, HW34228, HW34230, HW34231, HW34233, HW34234, HW34235, HW34236, HW34238, HW34239, HW34240, HW34241, HW34242, HW34243, HW34244, HW34245, HW34246, HW34247, HW34248, HW34249, HW34250, HW34253, HW34254, HW34255, HW34256, HW34257, HW34258, HW34259, HW34260, HW34261, HW34262, HW34263, HW34264, HW34265, HW34267, HW34276, HW34279, HW34282, HW34284, HW34285, HW34286, HW34287, HW34288, HW34289, HW34291, HW34294, HW34295, HW34297, HW34298, HW34299, HW34300, HW34302, HW34303, HW34304, HW34305, HW34306, HW34307, HW34308, HW34310, HW34311, HW34312, HW34313, HW34314, HW34315, HW34316, HW34318, HW34320, HW34321, HW34322, HW34323, HW34325, HW34332, HW34333, HW34334, HW34335, HW34338, HW34339, HW34353, HW34360, HW34385, HW34386, HW34387, HW34389, HW34390, HW34391, HW34392, HW34393, HW34394, HW34396, HW34397, HW34399, HW34400, HW34402, HW34403, HW34404, HW34405, HW34406, HW34407, HW34409, HW34410, HW34411, hw34413, hw34416, hw34417, HW34422, HW34423, HW34424, HW34430, HW34435, HW34441, HW34445, HW34447, HW34450, HW34451, HW34453, HW34455, HW34457, HW34458, HW34459, HW34460, HW34462, HW34463, HW34464, HW34465, HW34466, HW34467, HW34468, HW34469, HW34470, HW34471, HW34472, HW34473, HW34475, HW34476, HW34477, HW34479, HW34480, HW34481, HW34482, HW34483, HW34485, HW34486, HW34487, HW34488, HW34489, HW34492, HW34493, HW34494, HW34496, HW34498, HW34499, HW34500, HW34501, HW34502, HW34503, HW34504, HW34505, HW34506, HW34515, HW34525, HW34526, HW34527, HW34528, HW34529, HW34530, HW34531, HW34532, HW34533, HW34534, HW34535, HW34537, HW34538, HW34540, HW34541, HW34542, HW34543, HW34544, HW34545, HW34548, HW34549, HW34552, HW34553, HW34554, HW34558, HW34562, HW34564, HW34565, HW34566, HW34567, HW34568, HW34570, HW34571, HW34572, HW34573, HW34574, HW34575, HW34576, HW34577, HW34578, HW34579, HW34580, HW34581, HW34583, HW34584, HW34585, HW34587, HW34589, HW34592, HW34593, HW34597, HW34598, HW34599, HW34600, HW34601, HW34602, HW34604, HW34606, HW34608, HW34611, HW34612, HW34613, HW34614, HW34616, HW34626, HW34627, HW34632, HW34633, HW34634, HW34635, HW34638, HW34639, HW34640, HW34642, HW34644, HW34645, HW34646, HW34647, HW34648, HW34649, HW34650, HW34651, HW34652, HW34653, HW34654, HW34655, HW34657, HW34658, HW34659, HW34660, HW34661, HW34662, HW34663, HW34665, HW34667, HW34668, HW34669, HW34671, HW34672, HW34674, HW34675, HW34676, HW34677, HW34678, HW34679, HW34680, HW34681, HW34683, HW34684, HW34685, HW34686, HW34687, HW34688, HW34689, HW34690, HW34695, HW34696, HW34697, HW34698, HW34699, HW34701, HW34702, HW34705, HW34706, HW34707, HW34708, HW34709, HW34712, HW34714, HW34715, HW34716, HW34718, HW34721, HW34722, HW34725, HW34728, HW34729, HW34730, HW34731, HW34733, HW34735, HW34736, HW34740, HW34741, HW34744, HW34747, HW34754, HW34755, HW34756, HW34760, HW34763, HW34765, HW34766, HW34770, HW34771, HW34772, HW34773, HW34774, HW34775, HW34777, HW34778, HW34780, HW34781, HW34782, HW34783, HW34784, HW34786, HW34787, HW34788, HW34789, HW34790, HW34793, HW34794, HW34795, HW34796, HW34797, HW34798, HW34799, HW34800, HW34804, HW34807, HW34809, HW34811, HW34812, HW34814, HW34815, HW34816, HW34819, HW34820, HW34821, HW34822, HW34823, HW34825, HW34826, HW34827, HW34828, HW34830, HW34831, HW34832, HW34835, HW34843, HW34852, HW34854, HW34856, HW34857, HW34858, HW34859, HW34860, HW34861, HW34863, HW34865, HW34869, HW34870, HW34871, HW34872, HW34874, HW34878, HW34883, HW34887, HW34891, HW34896, HW34899, HW34917, HW34918, HW34921, HW34922, HW34926, HW34927, HW34929, HW34930, HW34931, HW34935, HW34937, HW34942, HW34943, HW34952, HW34956, HW34958, HW34961, HW34962, HW34964, HW34967, HW34969, HW34970, HW34971, HW34972, HW34973, HW34976, HW34978, HW34980, HW34981, HW34983, HW34984, HW34987, HW34988, HW34989, HW34993, HW34995, HW34998, HW34999, HW35001, HW35003, HW35004, HW35005, HW35006, HW35007, HW35008, HW35009, HW35010, HW35011, HW35013, HW35014, HW35015, HW35017, HW35018, HW35020, HW35022, HW35023, HW35026, HW35027, HW35029, HW35030, HW35036, HW35037, HW35042, HW35044, HW35045, HW35046, HW35047, HW35048, HW35050, HW35051, HW35053, HW35055, HW35058, HW35059, HW35060, HW35063, HW35066, HW35069, HW35071, HW35072, HW35073, HW35074, HW35075, HW35076, HW35077, HW35078, HW35079, HW35081, HW35082, HW35084, HW35087, HW35088, HW35089, HW35092, HW35096, HW35098, HW35100, HW35101, HW35103, HW35104, HW35105, HW35106, HW35107, HW35109, HW35110, HW35111, HW35112, HW35113, HW35115, HW35116, HW35117, HW35118, HW35126, HW35129, HW35130, HW35132, HW35135, HW35140, HW35152, HW35153, HW35159, HW35160, HW35163, HW35165, HW35166, HW35167, HW35168, HW35169, HW35170, HW35172, HW35173, HW35174, HW35175, HW35176, HW35177, HW35178, HW35179, HW35180, HW35181, HW35182, HW35183, HW35184, HW35190, HW35192, HW35193, HW35194, HW35195, HW35198, HW35199, HW35203, HW35206, HW35219, HW35221, HW35222, HW35223, HW35224, HW35225, HW35226, HW35227, HW35229, HW35231, HW35232, HW35233, HW35234, HW35235, HW35236, HW35238, HW35239, HW35240, HW35241, HW35242, HW35243, HW35244, HW35245, HW35246, HW35247, HW35249, HW35253, HW35254, HW35255, HW35256, HW35257, HW35258, HW35259, HW35261, HW35262, HW35263, HW35264, HW35265, HW35266, HW35267, HW35268, HW35269, HW35270, HW35271, HW35273, HW35274, HW35276, HW35277, HW35280, HW35285, HW35286, HW35287, HW35288, HW35289, HW35291, HW35292, HW35293, HW35294, HW35295, HW35296, HW35299, HW35301, HW35302, HW35347, HW35354, HW35358, HW35399, HW35403, HW35406, HW35410, HW35413, HW35414, HW35415, HW35416, HW35417, HW35420, HW35422, HW35424, HW35425, HW35426, HW35427, HW35428, HW35429, HW35430, HW35431, HW35433, HW35434, HW35435, HW35436, HW35437, HW35438, HW35439, HW35440, HW35441, HW35442, HW35443, HW35444, HW35445, HW35446, HW35447, HW35448, HW35449, HW35450, HW35451, HW35452, HW35453, HW35454, HW35455, HW35456, HW35457, HW35459, HW35460, HW35461, HW35462, HW35463, HW35466, HW35469, HW35471, HW35472, HW35473, HW30051, HW30066, HW30169, HW30330, HW30573, HW30605, HW30613, HW30628, HW30677, HW30700, HW30703, HW30884, HW30904, HW30912, HW30992, HW30999, HW31004, HW31013, HW31038, HW31046, HW31053, HW31060, HW31149, HW31151, HW31199, HW31225, HW31230, HW31321, HW31367, HW31407, HW31463, HW31537 GTIN 00888707003261, Serial Numbers: HW40002, HW40004, HW40006, HW40008, HW40009, HW40010, HW40012, HW40013, HW40015, HW40016, HW40017, HW40018, HW40019, HW40021, HW40022, HW40023, HW40024, HW40025, HW40026, HW40028, HW40030, HW40032, HW40033, HW40035, HW40036, HW40037, HW40038, HW40039, HW40041, HW40042, HW40043, HW40044, HW40045, HW40046, HW40047, HW40048, HW40049, HW40050, HW40051, HW40054, HW40055, HW40057, HW40058, HW40059, HW40060, HW40061, HW40062, HW40063, HW40064, HW40065, HW40066, HW40067, HW40068, HW40069, HW40070, HW40071, HW40072, HW40073, HW40074, HW40075, HW40076, HW40077, HW40078, HW40079, HW40080, HW40081, HW40082, HW40083, HW40084, HW40085, HW40086, HW40087, HW40088, HW40089, HW40090, HW40091, HW40092, HW40093, HW40094, HW40095, HW40096, HW40097, HW40098, HW40099, HW40100, HW40102, HW40103, HW40105, HW40106, HW40107, HW40108, HW40109, HW40110, HW40111, HW40112, HW40113, HW40114, HW40115, HW40116, HW40117, HW40118, HW40119, HW40120, HW40121, HW40122, HW40123, HW40124, HW40125, HW40126, HW40127, HW40128, HW40129, HW40130, HW40131, HW40132, HW40135, HW40136, HW40137, HW40138, HW40139, HW40140, HW40142, HW40143, HW40144, HW40145, HW40146, HW40147, HW40148, HW40149, HW40150, HW40151, HW40152, HW40153, HW40154, HW40155, HW40156, HW40157, HW40158, HW40159, HW40160, HW40161, HW40163, HW40164, HW40165, HW40166, HW40167, HW40168, HW40169, HW40170, HW40171, HW40172, HW40174, HW40175, HW40176, HW40177, HW40178, HW40179, HW40180, HW40181, HW40182, HW40184, HW40185, HW40186, HW40187, HW40188, HW40189, HW40190, HW40191, HW40192, HW40193, HW40194, HW40195, HW40196, HW40197, HW40198, HW40199, HW40200, HW40201, HW40202, HW40203, HW40204, HW40206, HW40207, HW40208, HW40209, HW40210, HW40211, HW40212, HW40213, HW40214, HW40215, HW40217, HW40218, HW40219, HW40220, HW40222, HW40223, HW40224, HW40225, HW40226, HW40227, HW40228, HW40229, HW40230, HW40231, HW40232, HW40233, HW40234, HW40235, HW40236, HW40237, HW40238, HW40239, HW40240, HW40241, HW40242, HW40243, HW40244, HW40245, HW40246, HW40247, HW40248, HW40249, HW40250, HW40251, HW40252, HW40253, HW40254, HW40255, HW40256, HW40257, HW40258, HW40259, HW40260, HW40261, HW40262, HW40263, HW40264, HW40265, HW40266, HW40267, HW40268, HW40269, HW40270, HW40271, HW40272, HW40273, HW40274, HW40275, HW40276, HW40277, HW40278, HW40279, HW40280, HW40281, HW40282, HW40283, HW40284, HW40285, HW40286, HW40287, HW40288, HW40289, HW40290, HW40291, HW40292, HW40293, HW40294, HW40295, HW40296, HW40297, HW40298, HW40299, HW40300, HW40301, HW40302, HW40303, HW40304, HW40305, HW40306, HW40307, HW40308, HW40309, HW40310, HW40311, HW40312, HW40313, HW40314, HW40315, HW40316, HW40317, HW40318, HW40319, HW40320, HW40321, HW40322, HW40323, HW40324, HW40325, HW40326, HW40327, HW40328, HW40329, HW40330, HW40331, HW40332, HW40333, HW40334, HW40335, HW40337, HW40338, HW40339, HW40340, HW40341, HW40359, HW40360, HW40361, HW40362, HW40364, HW40371, HW40372, HW40373, HW40375, HW40376, HW40377, HW40378, HW40379, HW40380, HW40381, HW40382, HW40384, HW40385, HW40386, HW40387, HW40388, HW40389, HW40390, HW40391, HW40392, HW40393, HW40394, HW40395, HW40396, HW40397, HW40399, HW40400, HW40401, HW40402, HW40403, HW40404, HW40405, HW40406, HW40407, HW40408, HW40409, HW40410, HW40411, HW40432, HW40433, HW40434, HW40435, HW40436, HW40437, HW40438, HW40440, HW40441, HW40442, HW40443, HW40444, HW40445, HW40446, HW40447, HW40448, HW40449, HW40451, HW40452, HW40453, HW40454, HW40455, HW40456, HW40457, HW40460, HW40461, HW40462, HW40463, HW40464, HW40466, HW40467, HW40468, HW40469, HW40470, HW40481, HW40482, HW40483, HW40484, HW40485, HW40486, HW40487, HW40488, HW40489, HW40490, HW40491, HW40492, HW40493, HW40494, HW40496, HW40497, HW40498, HW40499, HW40500, HW40501, HW40502, HW40503, HW40504, HW40505, HW40506, HW40507, HW40508, HW40509, HW40510, HW40511, HW40512, HW40513, HW40514, HW40515, HW40516, HW40517, HW40518, HW40519, HW40520, HW40521, HW40522, HW40523, HW40524, HW40525, HW40526, HW40527, HW40528, HW40529, HW40530, HW40531, HW40532, HW40533, HW40534, HW40535, HW40536, HW40537, HW40538, HW40539, HW40540, HW40541, HW40542, HW40543, HW40544, HW40545, HW40546, HW40547, HW40548, HW40549, HW40550, HW40551, HW40558, HW40559, HW40560, HW40561, HW40562, HW40563, HW40566, HW40567, HW40568, HW40569, HW40570, HW40571, HW40572, HW40573, HW40574, HW40575, HW40576, HW40577, HW40578, HW40581, HW40582, HW40583, HW40584, HW40585, HW40589, HW40590, HW40591, HW40592, HW40593, HW40594, HW40595, HW40596, HW40597, HW40598, HW40601, HW40605, HW40606, HW40610, HW40616, HW40617, HW40620, HW40621, HW40622, HW40623, HW40627, HW40628, HW40629, HW40630, HW40631, HW40633, HW40634, HW40635, HW40636, HW40637, HW40638, HW40639, HW40640, HW40641, HW40642, HW40643, HW40644, HW40645, HW40646, HW40647, HW40648, HW40671, HW40672, HW40673, HW40674, HW40676, HW40677, HW40678, HW40679, HW40680, HW40681, HW40682, HW40683, HW40684, HW40685, HW40686, HW40687, HW40688, HW40689, HW40690, HW40691, HW40692, HW40693, HW40694, HW40695, HW40696, HW40697, HW40698, HW40699, HW40700, HW40703, HW40704, HW40705, HW40706, HW40707, HW40708, HW40709, HW40710, HW40711, HW40712, HW40713, HW40714, HW40715, HW40716, HW40717, HW40718, HW40719, HW40720, HW40721, HW40722, HW40723, HW40724, HW40725, HW40726, HW40727, HW40728, HW40729, HW40730, HW40731, HW40732, HW40733, HW40734, HW40735, HW40736, HW40737, HW40738, HW40739, HW40740, HW40741, HW40742, HW40743, HW40744, HW40745, HW40746, HW40747, HW40748, HW40749, HW40750, HW40751, HW40752, HW40753, HW40754, HW40755, HW40756, HW40757, HW40758, HW40759, HW40760, HW40761, HW40762, HW40763, HW40764, HW40766, HW40767, HW40768, HW40769, HW40770, HW40771, HW40772, HW40773, HW40774, HW40775, HW40776, HW40777, HW40778, HW40779, HW40780, HW40781, HW40783, HW40784, HW40785, HW40786, HW40790, HW40791, HW40792, HW40793, HW40794, HW40795, HW40796, HW40797, HW40798, HW40799, HW40800, HW40801, HW40802, HW40803, HW40804, HW40805, HW40806, HW40807, HW40808, HW40809, HW40810, HW40811, HW40812, HW40813, HW40814, HW40815, HW40817, HW40818, HW40819, HW40820, HW40821, HW40822, HW40823, HW40824, HW40825, HW40826, HW40827, HW40828, HW40829, HW40830, HW40831, HW40832, HW40833, HW40834, HW40837, HW40838, HW40839, HW40840, HW40841, HW40857, HW40858, HW40859, HW40860, HW40861, HW40862, HW40863, HW40864, HW40865, HW40866, HW40867, HW40868, HW40869, HW40870, HW40872, HW40873, HW40874, HW40875, HW40876, HW40877, HW40878, HW40879, HW40880, HW40882, HW40883, HW40884, HW40885, HW40886, HW40887, HW40888, HW40889, HW40890, HW40891, HW40892, HW40893, HW40894, HW40896, HW40897, HW40899, HW40902, HW40903, HW40904, HW40905, HW40906, HW40907, HW40908, HW40910, HW40911, HW40912, HW40913, HW40914, HW40915, HW40916, HW40917, HW40918, HW40919, HW40920, HW40921, HW40922, HW40923, HW40924, HW40925, HW40926, HW40927, HW40928, HW40929, HW40930, HW40931, HW40932, HW40933, HW40935, HW40936, HW40937, HW40939, HW40940, HW40941, HW40942, HW40943, HW40944, HW40946, HW40947, HW40948, HW40949, HW40962, HW40963, HW40964, HW40965, HW40966, HW40967, HW40968, HW40969, HW40970, HW40971, HW40972, HW40973, HW40974, HW40975, HW40976, HW40977, HW40979, HW40982, HW40983, HW40984, HW40985, HW40986, HW40987, HW40988, HW40989, HW40990, HW40991, HW40992, HW40993, HW40994, HW40995, HW40996, HW40997, HW40998, HW40999, HW41001, HW41002, HW41004, HW41005, HW41006, HW41007, HW41008, HW41009, HW41010, HW41011, HW41012, HW41014, HW41015, HW41016, HW41017, HW41018, HW41019, HW41020, HW41021, HW41022, HW41023, HW41024, HW41025, HW41027, HW41029, HW41030, HW41031, HW41032, HW41033, HW41034, HW41035, HW41037, HW41038, HW41039, HW41040, HW41042, HW41043, HW41044, HW41046, HW41051, HW41052, HW41053, HW41054, HW41055, HW41057, HW41058, HW41059, HW41060, HW41061, HW41062, HW41063, HW41064, HW41065, HW41066, HW41067, HW41068, HW41069, HW41070, HW41071, HW41072, HW41073, HW41075, HW41076, HW41077, HW41078, HW41080, HW41081, HW41084, HW41086, HW41088, HW41089, HW41090, HW41091, HW41092, HW41093, HW41097, HW41098, HW41099, HW41100, HW41102, HW41103, HW41104, HW41105, HW41106, HW41107, HW41108, HW41111, HW41112, HW41115, HW41118, HW41119, HW41120, HW41121, HW41122, HW41123, HW41124, HW41125, HW41126, HW41127, HW41128, HW41130, HW41131, HW41132, HW41133, HW41135, HW41136, HW41137, HW41138, HW41139, HW41140, HW41141, HW41142, HW41143, HW41144, HW41145, HW41146, HW41147, HW41148, HW41149, HW41150, HW41152, HW41153, HW41154, HW41155, HW41157, HW41158, HW41159, HW41160, HW41161, HW41162, HW41164, HW41165, HW41166, HW41167, HW41168, HW41169, HW41170, HW41171, HW41172, HW41173, HW41174, HW41176, HW41177, HW41178, HW41179, HW41180, HW41181, HW41182, HW41184, HW41185, HW41186, HW41187, HW41188, HW41189, HW41190, HW41193, HW41194, HW41195, HW41196, HW41197, HW41198, HW41199, HW41200, HW41201, HW41202, HW41203, HW41204, HW41205, HW41206, HW41207, HW41208, HW41210, HW41212, HW41213, HW41215, HW41216, HW41217, HW41218, HW41219, HW41220, HW41221, HW41223, HW41224, HW41225, HW41226, HW41227, HW41228, HW41229, HW41230, HW41231, HW41232, HW41233, HW41234, HW41235, HW41236, HW41237, HW41238, HW41239, HW41241, HW41242, HW41243, HW41244, HW41245, HW41246, HW41247, HW41248, HW41249, HW41250, HW41267, HW41268, HW41272, HW41273, HW41274, HW41275, HW41276, HW41277, HW41278, HW41279, HW41280, HW41281, HW41282, HW41283, HW41284, HW41285, HW41286, HW41287, HW41288, HW41289, HW41291, HW41293, HW41294, HW41295, HW41296, HW41297, HW41298, HW41299, HW41300, HW41301, HW41302, HW41303, HW41304, HW41305, HW41307, HW41310, HW41312, HW41318, HW41319, HW41320, HW41321, HW41322, HW41323, HW41324, HW41325, HW41326, HW41327, HW41329, HW41330, HW41331, HW41332, HW41333, HW41334, HW41336, HW41337, HW41338, HW41339, HW41341, HW41343, HW41344, HW41345, HW41346, HW41347, HW41348, HW41349, HW41350, HW41351, HW41352, HW41354, HW41355, HW41357, HW41358, HW41359, HW41360, HW41361, HW41362, HW41363, HW41364, HW41368, HW41369, HW41371, HW41372, HW41373, HW41374, HW41376, HW41377, HW41378, HW41379, HW41380, HW41381, HW41382, HW41383, HW41384, HW41385, HW41386, HW41387, HW41388, HW41389, HW41390, HW41391, HW41392, HW41393, HW41394, HW41395, HW41396, HW41398, HW41399, HW41400, HW41401, HW41402, HW41404, HW41405, HW41406, HW41407, HW41408, HW41409, HW41410, HW41412, HW41413, HW41414, HW41415, HW41416, HW41417, HW41418, HW41419, HW41420, HW41422, HW41423, HW41424, HW41425, HW41426, HW41427, HW41428, HW41429, HW41430, HW41431, HW41432, HW41433, HW41434, HW41435, HW41436, HW41437, HW41438, HW41439, HW41440, HW41441, HW41442, HW41443, HW41444, HW41445, HW41446, HW41447, HW41448, HW41449, HW41450, HW41452, HW41453, HW41454, HW41455, HW41456, HW41458, HW41459, HW41460, HW41461, HW41462, HW41463, HW41465, HW41466, HW41467, HW41468, HW41469, HW41470, HW41471, HW41472, HW41473, HW41474, HW41475, HW41476, HW41477, HW41478, HW41479, HW41480, HW41481, HW41482, HW41483, HW41484, HW41486, HW41488, HW41489, HW41490, HW41491, HW41492, HW41493, HW41494, HW41495, HW41496, HW41497, HW41498, HW41499, HW41500, HW41502, HW41503, HW41504, HW41505, HW41506, HW41507, HW41508, HW41509, HW41644, HW41645, HW41646, HW41648, HW41649, HW41650, HW41651, HW41653, HW41654

Product: Heartware HVAD Pump Implant Kit, Product (REF) Number 1104

GTIN 00888707002028, Serial Numbers: HW28848, hw29011, HW29154, HW29211, HW29248, HW29249, HW29273, HW29329, HW29426, HW29465, HW29472, HW29522, HW29534, HW29548, HW29549, HW29567, HW29588, HW29593, HW29602, HW29612, HW29667, HW29700, HW29786, HW29815, HW29915, HW29928, HW29949, HW30039, HW30082, HW30083, HW30150, HW30153, HW30208, HW30211, HW30226, HW30320, HW30342, HW30358, HW30360, HW30363, HW30378, HW30380, HW30382, HW30390, HW30398, HW30400, HW30402, HW30406, HW30410, HW30430, HW30475, HW30484, HW30494, HW30498, HW30595, HW30596, HW30597, HW30601, HW30604, HW30651, HW30768, HW30769, HW30770, HW30771, HW30814, HW30821, HW30829, HW30863, HW30865, HW30867, HW30871, HW30953, HW30961, HW30962, HW30966, HW30971, HW30972, HW30974, HW31020, HW31076, HW31101, HW31103, HW31104, HW31107, HW31113, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31232, HW31235, HW31242, HW31244, HW31249, HW31254, HW31255, HW31260, HW31261, HW31262, HW31267, HW31383, HW31387, HW31388, HW31399, HW31409, HW31410, HW31411, HW31412, HW31414, hw31445, HW31446, hw31447, hw31448, hw31449, hw31451, HW31452, hw31453, hw31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW31843, HW31844, HW31845, HW31846, HW31847, HW31849, HW31855, HW31858, HW31876, HW31883, HW31944, HW31947, HW31979, HW31981, HW31986, HW31987, HW31988, HW31989, HW31991, HW32068, HW32116, HW32121, HW32141, HW32143, HW32156, HW32159, HW32161, HW32162, HW32164, HW32167, HW32172, HW32179, HW32189, HW32190, HW32192, HW32193, HW32194, HW32197, HW32199, HW32201, HW32204, HW32206, HW32209, HW32210, HW32214, HW32215, HW32216, HW32218, HW32220, HW32222, HW32223, HW32224, HW32228, HW32229, HW32230, HW32231, HW32248, HW32258, HW32259, HW32260, HW32261, HW32273, HW32279, HW32281, HW32285, HW32286, HW32290, HW32292, HW32315, HW32335, HW32357, HW32386, HW32393, HW32400, HW32419, HW32423, HW32426, HW32427, HW32457, HW32458, HW32459, HW32464, HW32465, HW32468, HW32470, HW32471, HW32472, HW32474, HW32479, HW32499, HW32504, HW32508, HW32509, HW32510, HW32511, HW32516, HW32534, HW34001, HW34002, HW34025, HW34034, HW34035, HW34036, HW34037, HW34038, HW34040, HW34041, HW34042, HW34043, HW34044, HW34045, HW34046, HW34047, HW34048, HW34051, HW34066, HW34096, HW34100, HW34104, HW34106, HW34109, HW34110, HW34111, HW34113, HW34117, HW34121, HW34126, HW34151, HW34169, HW34179, HW34181, HW34186, HW34187, HW34192, HW34193, HW34196, HW34197, HW34202, HW34204, HW34205, HW34207, HW34209, HW34211, HW34226, HW34317, HW34319, HW34326, HW34328, HW34329, HW34330, HW34331, HW34336, HW34342, HW34344, HW34347, HW34368, HW34369, HW34371, HW34372, HW34373, HW34375, HW34376, HW34377, HW34378, HW34379, HW34425, HW34427, HW34428, HW34429, HW34432, HW34446, HW34495, HW34519, HW34520, HW34521, HW34522, HW34523, HW34546, HW34547, HW34550, HW34551, HW34555, HW34556, HW34588, HW34590, HW34596, HW34603, HW34605, HW34609, HW34610, HW34643, HW34673, HW34752, HW34768, HW34805, HW34806, HW34808, HW34810, HW34824, HW34840, HW34842, HW34845, HW34866, HW34868, HW34877, HW34902, HW34903, HW34904, HW34908, HW34910, HW34913, HW34914, HW34923, HW34924, HW34925, HW34928, HW34933, HW34934, HW34938, HW34939, HW34944, HW34946, HW34947, HW34948, HW34949, HW34957, HW34979, HW34990, HW34997, HW35012, HW35032, HW35099, HW35122, HW35123, HW35124, HW35125, HW35127, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35142, HW35143, HW35161, HW35189, HW35191, HW35204, HW35205, HW35209, HW35211, HW35212, HW35213, HW35214, HW35215, HW35220, HW35284, HW35305, HW35317, HW35319, HW35321, HW35324, HW35325, HW35326, HW35332, HW35334, HW35337, HW35339, HW35340, HW35341, HW35357, HW35360, HW35361, HW35367, HW35385, HW35464, HW35477, HW35478, HW35479, HW35480, HW35481, HW35482, HW35483, HW35487, HW35488, HW35489, HW35492, HW35493, HW35494, HW35495, HW35499, HW35500, HW35501, HW35502, HW35504, HW35506, HW35508, HW35534, HW35535, HW35539, HW35540, HW35541, HW35542, HW35543, HW35545, HW35548, HW35563, HW35577, HW35578, HW35580, HW35582, HW35583, HW35584, HW35586, HW35587, HW35588, HW35624, HW35625, HW35626, HW35627, HW35628, HW35629, HW35630, HW35631, HW35632, HW35633, HW35634, HW35635, HW35636, HW35637, HW35639, HW35641, HW35644, HW35646, HW35647, HW35668, HW35669, HW35670, HW35671, HW35673, HW35674, HW35676, HW35677, HW35678, HW35680, HW35681, HW35682, HW35683, HW35684, HW35686, HW35687, HW35688, HW35689, HW35690, HW35691, HW35692, HW35693, HW35695, HW35696, HW35697, HW35698, HW35701, HW35702, HW35703, HW35704, HW35705, HW35707, HW35708, HW35730, HW35731 GTIN 00888707002387, Serial Numbers: HW28851, HW29783, HW29793, HW29794, HW29827, HW29870, HW29918, HW30045, HW30046, HW30505, HW30765, HW30842, HW30844, HW30845, HW30846, hw30978, HW31075, HW31077, HW31080, hw31089, hw31091, HW31095, HW31161, HW31342, HW31348, HW31555, HW31556, HW31557, HW31683, HW31860, HW31903, HW31920, HW31924, HW31926, HW32026, HW32027, HW32028, HW32149, HW32153, HW32163, HW32282, HW32513, HW32514, HW32562, HW32563, HW34004, HW34006, HW34091, HW34092, HW34125, HW34272, HW34273, HW34274, HW34349, HW34350, HW34351, HW34352, HW34357, HW34358, HW34359, HW34366, HW34374, HW34436, HW34953, HW34968, HW35080, HW35144, HW35145, HW35148, HW35327, HW35342, HW35344, HW35537, HW35596, HW35603, HW35604, HW35605, HW35606, HW35607, HW35713, HW35714, HW35717, HW35718, HW35721, HW35723 GTIN 00888707001649, Serial Numbers: HW29132, HW29232, hw29653, HW29682, HW29684, HW29705, HW29864, HW29985, HW29991, HW30096, HW30100, HW30145, HW30146, HW30373, HW30374, HW30421, HW30525, HW30529, HW30726, HW30738, HW30836, HW30840, HW30862, HW30939, hw30949, hw30950, HW31048, HW31071, HW31082, HW31088, hw31133, hw31394, HW31415, HW31417, HW31420, HW31421, HW31423, hw31483, hw31505, hw31506, hw31507, hw31510, HW31511, hw31512, hw31513, hw31515, hw31516, hw31517, HW31546, HW31551, HW31554, HW31566, HW31587, HW31588, HW31589, HW31590, HW31592, HW31632, HW31639, HW31685, HW31795, HW31801, HW31806, HW31808, HW31809, HW31811, HW31812, HW31813, HW31815, HW31891, HW31892, HW31893, HW31919, HW31921, HW31973, HW31982, HW31985, HW32000, HW32001, HW32014, HW32015, HW32018, HW32021, HW32022, HW32024, HW32042, HW32050, HW32055, HW32056, HW32064, HW32081, HW32094, HW32112, HW32123, HW32138, HW32147, HW32186, HW32245, HW32255, HW32264, HW32265, HW32268, HW32270, HW32301, HW32394, HW32410, HW32420, HW32558, HW32559, HW32560, HW32561, HW34029, HW34031, HW34093, HW34094, HW34132, HW34148, HW34180, HW34266, HW34268, HW34269, HW34270, HW34271, HW34296, HW34301, HW34324, HW34327, HW34340, HW34341, HW34343, HW34345, HW34346, HW34348, HW34418, HW34420, HW34431, HW34507, HW34508, HW34641, HW34692, HW34745, HW34764, HW34836, HW34906, HW34932, HW34936, HW34940, HW34941, HW34963, HW34977, HW34992, HW34994, HW35019, HW35021, HW35033, HW35035, HW35038, HW35041, HW35065, HW35068, HW35085, HW35090, HW35094, HW35114, HW35147, HW35157, HW35196, HW35197, HW35210, HW35237, HW35250, HW35290, HW35308, HW35309, HW35310, HW35311, HW35312, HW35313, HW35314, HW35315, HW35318, HW35320, HW35328, HW35329, HW35330, HW35333, HW35338, HW35349, HW35365, HW35366, HW35368, HW35370, HW35371, HW35372, HW35373, HW35375, HW35378, HW35402, HW35404, HW35405, HW35408, HW35409, HW35411, HW35412, HW35418, HW35421, HW35423, HW35465, HW35470, HW35475, HW35476, HW35485, HW35486, HW35546, HW35547, HW35550, HW35551, HW35552, HW35553, HW35554, HW35555, HW35556, HW35557, HW35558, HW35559, HW35560, HW35564, HW35598, HW35599, HW35602, HW35640, HW35657, HW35658, HW35659, HW35662, HW35663, HW35664, HW35665, HW35666, HW35667, HW35672, HW35694, HW35719, HW35750, HW35753, HW36121, HW36154, HW36165, HW36168 GTIN 00888707000581, Serial Numbers: HW29203, HW29425, HW29427, HW29428, HW29430, HW29439, HW29517, HW29679, HW29680, HW30589, HW30638, HW30706, HW30876, HW31144, HW31187, hw31376, hw31380, HW31442, HW31727, HW31998, HW32023, HW32416, HW34017 GTIN 00888707002417, Serial Numbers: HW29478, HW30381, HW30831, HW34380, HW34421, HW35348, HW35613, HW35756, HW35761, HW35763 GTIN 00888707002493, Serial Numbers: HW29483, HW29697, HW29698, hw31178, HW31520, HW31821, HW31823, HW31827, HW32086, HW32242, HW32246, HW32518, HW32519, HW34021, HW34365, HW34367, HW34792, HW34915, HW35155, HW35158, HW35252, HW35343, HW35345, HW35346, HW35350, HW35400, HW35401, HW35529, HW35530, HW35574, HW35591, HW35660, HW35661, HW35785 GTIN 00888707002400, Serial Numbers: HW29518, HW29693, HW30092, HW32257, HW34012, HW34210, HW35034, HW35154, HW35573, HW35653 GTIN 00888707002547, Serial Numbers: HW29561, HW29601, HW29931, HW30502, HW30593, HW30619, HW30632, HW30783, HW30796, HW30819, HW30826, HW31136, HW31140, HW31141, HW31156, HW31157, HW31158, HW31382, HW31393, HW31406, HW31408, HW31413, HW31416, HW31426, HW31429, HW31553, HW31791, HW31937, HW31994, HW32118, HW32269, HW32309, HW32336, HW32347, HW32373, HW32385, HW32522, HW32523, HW32524, HW32554, HW32557, HW34003, HW34007, HW34008, HW34049, HW34050, HW34053, HW34054, HW34382, HW34383, HW34513, HW34514, HW34516, HW34517, HW34518, HW35251, HW35275 GTIN 00888707000680, Serial Numbers: HW29571, HW29578, HW29845, HW30635, HW30639, HW30711, HW31150 GTIN 00888707002394, Serial Numbers: HW30469, HW30506, HW30508, HW30509, HW30510, HW30511, HW30512, HW30655, HW31580, HW31582, HW31583, HW31584, HW31992, HW31993, HW32200, HW32207, HW32217, HW32238, HW32239, HW32240, HW32515, HW32517, HW34022, HW34023, HW34395, HW34461, HW34557, HW34561, HW34582, HW34751, HW34950, HW34955, HW34991, HW34996, HW35016, HW35149, HW35150, HW35186, HW35336, HW35386, HW35397, HW35484, HW35509, HW35510, HW35538, HW35566, HW35609, HW35610, HW35611, HW35648, HW35649, HW35651, HW35679, HW35699, HW35700, HW35706, HW35776, HW35779 GTIN 00888707000239, Serial Numbers: HW30634, HW30645, HW30877, HW34737 GTIN 00888707002530, Serial Numbers: HW30797, HW31108, HW31440, HW31828, HW31928, HW32182, HW32253, HW32263, HW34559, HW35000, HW35162, HW35532, HW35533, HW35590 GTIN 00888707002523, Serial Numbers: HW30859, HW31703, HW31704, HW31859, HW32030, HW32036, HW32040, HW32102, HW32520, HW32521, HW34018, HW34020, HW34027, HW34028, HW34986, HW35040, HW35043, HW35049, HW35216, HW35217, HW35218, HW35490, HW35531, HW35619, HW35786 GTIN 00888707002431, Serial Numbers: hw30979, hw31123, HW32029, HW32180, HW34024, HW34381, HW34615, HW35119, HW35733 GTIN 00888707002585, Serial Numbers: hw31079, hw31081, hw31168, hw31170, HW35095, HW35164, HW35351, HW35353, HW35355, HW35496, HW35497, HW35575, HW35576 GTIN 00888707002516, Serial Numbers: hw31147, hw31162, HW32507, HW34524, HW35474 GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36007, HW36008, HW36009, HW36010, HW36013, HW36014, HW36015, HW36018, HW36019, HW36020, HW36021, HW36067, HW36068, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36182, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36196, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36249, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36306, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36337, HW36354, HW36355, HW36356, HW36357, HW36358, HW36359, HW36360, HW36361, HW36362, HW36363, HW36396, HW36397, HW36398, HW36399, HW36400, HW36401, HW36403, HW36404, HW36405, HW36406, HW36407, HW36408, HW36409, HW36410, HW36411, HW36412, HW36419, HW36420, HW36428, HW36429, HW36430, HW36432, HW36433, HW36434, HW36435, HW36436, HW36437, HW36438, HW36500, HW36501, HW36502, HW36503, HW36504, HW36505, HW36506, HW36507, HW36508, HW36509, HW36510, HW36511, HW36513, HW36514, HW36515, HW36530, HW36553, HW36554, HW36555, HW36556, HW36557, HW36558, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36632, HW36633, HW36636, HW36637, HW36655, HW36659, HW36660, HW36662, HW36663, HW36664, HW36669, HW36670, HW36671, HW36672, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36853, HW36854, HW36855, HW36898, HW36899, HW36900, HW36903, HW36919, HW36921 GTIN 00888707002486, Serial Numbers: HW31444, HW31569, HW31673, HW31814, HW31817, HW31818, HW31820, HW31824, HW31825, HW31826, HW31872, HW31873, HW31875, HW31877, HW31927, HW31932, HW31934, HW31939, HW31940, HW31941, HW31995, HW31996, HW31997, HW31999, HW32002, HW32008, HW32009, HW32010, HW32011, HW32013, HW32032, HW32034, HW32038, HW32046, HW32053, HW32057, HW32062, HW32065, HW32071, HW32085, HW32109, HW32165, HW32166, HW32195, HW32205, HW32211, HW32221, HW32236, HW32243, HW32250, HW32506, HW34015, HW34122, HW34123, HW34124, HW34251, HW34252, HW34275, HW34277, HW34280, HW34354, HW34355, HW34356, HW34361, HW34364, HW34433, HW34434, HW34437, HW34439, HW34440, HW34442, HW34443, HW34444, HW34452, HW34454, HW34619, HW34620, HW34621, HW34622, HW34623, HW34624, HW34629, HW34630, HW34631, HW34636, HW34656, HW34719, HW34738, HW34739, HW34742, HW34748, HW34749, HW34750, HW34753, HW34757, HW34758, HW34761, HW34762, HW34767, HW34769, HW34779, HW34818, HW34853, HW34867, HW34873, HW34879, HW34880, HW34882, HW34885, HW34888, HW34890, HW34897, HW34898, HW34900, HW34905, HW34909, HW34911, HW34912, HW34945, HW34954, HW34960, HW35171, HW35228, HW35230, HW35278, HW35282, HW35283, HW35297, HW35298, HW35300, HW35303, HW35304, HW35306, HW35307, HW35512, HW35513, HW35514, HW35516, HW35517, HW35518, HW35519, HW35520, HW35521, HW35522, HW35523, HW35525, HW35526, HW35527, HW35528, HW35565, HW35567, HW35568, HW35569, HW35570, HW35593, HW35600, HW35612, HW35614, HW35615, HW35616, HW35617, HW35618, HW35645, HW35650, HW35652, HW35685, HW35725, HW35734, HW35737, HW35738, HW35740, HW35742, HW35743, HW35744, HW35745, HW35746, HW35747, HW35748, HW35751, HW35752, HW35760, HW35762, HW35765 GTIN 00888707002462, Serial Numbers: HW31586, HW31700, HW32035 GTIN 00888707002424, Serial Numbers: HW31698, HW31851 GTIN 00888707002448, Serial Numbers: HW31779, HW31780, HW32546, HW34095, HW34617, HW35398, HW35511, HW35589, HW35597 GTIN 00888707002455, Serial Numbers: HW31852, HW31856, HW32025, HW32198, HW34026, HW34637, HW35544 GTIN 00888707006019, Serial Numbers: HW31983, HW34720, HW34974, HW35376, HW35377, HW35849, HW35866, HW35869, HW35871, HW35873, HW35877, HW35878, HW35879, HW35880, HW35998, HW36000, HW36056, HW36057, HW36058, HW36059, HW36060, HW36061, HW36062, HW36063, HW36113, HW36114, HW36115, HW36116, HW36117, HW36118, HW36119, HW36120, HW36145, HW36146, HW36155, HW36156, HW36157, HW36158, HW36159, HW36167, HW36221, HW36222, HW36223, HW36350, HW36351, HW36352 GTIN 00888707006408, Serial Numbers: HW34292, HW35932, HW36083, HW36084, HW36087, HW36129, HW36130, HW36171, HW36172, HW36173, HW36212, HW36247, HW36250, HW36261, HW36263, HW36264, HW36265, HW36266, HW36348, HW36349, HW36413, HW36414, HW36415, HW36416, HW36594, HW36638 GTIN 00888707002554, Serial Numbers: HW34337, HW34362, HW34484, HW34591, HW34594, HW34625, HW34682, HW34693, HW34732, HW34833, HW34838, HW34846, HW34876, HW34884, HW34889, HW35052, HW35057, HW35061, HW35067, HW35316, HW35323, HW35359, HW35362, HW35363, HW35364, HW35458, HW35536, HW35585, HW35620, HW35622, HW35623, HW35709, HW35710, HW35728, HW35732, HW35758, HW35759, HW35764, HW35767, HW35771, HW35772, HW35775, HW35777, HW35780, HW35782 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707002141, Serial Numbers: HW34848, HW34849, HW35711 GTIN 00888707006323, Serial Numbers: HW34982, HW35031, HW35379, HW35380, HW35381, HW35382, HW35383, HW35384, HW35388, HW35389, HW35390, HW35391, HW35392, HW35621, HW35642, HW35654, HW35712, HW35722, HW35727, HW35729, HW35736, HW35755, HW35770, HW35781, HW35783, HW35977, HW36024, HW36025, HW36027, HW36028, HW36029, HW36030, HW36032, HW36033, HW36034, HW36042, HW36043, HW36044, HW36045, HW36046, HW36064, HW36065, HW36072, HW36073, HW36074, HW36075, HW36076, HW36077, HW36078, HW36079, HW36080, HW36081, HW36082, HW36123, HW36124, HW36125, HW36126, HW36127, HW36128, HW36133, HW36134, HW36135, HW36136, HW36137, HW36139, HW36140, HW36141, HW36142, HW36143, HW36144, HW36147, HW36148, HW36149, HW36150, HW36151, HW36152, HW36153, HW36187, HW36188, HW36189, HW36190, HW36191, HW36202, HW36203, HW36204, HW36206, HW36207, HW36208, HW36209, HW36210, HW36234, HW36235, HW36236, HW36237, HW36238, HW36239, HW36242, HW36244, HW36245, HW36267, HW36268, HW36271, HW36272, HW36274, HW36275, HW36284, HW36286, HW36290, HW36291, HW36292, HW36293, HW36295, HW36296, HW36297, HW36339, HW36340, HW36342, HW36343, HW36344, HW36346, HW36364, HW36366, HW36367, HW36375, HW36378, HW36379, HW36380, HW36439, HW36440, HW36441, HW36443, HW36444, HW36445, HW36446, HW36450, HW36451, HW36452, HW36453, HW36454, HW36455, HW36456, HW36520, HW36521, HW36522, HW36524, HW36528, HW36529, HW36532, HW36533, HW36534, HW36535, HW36537, HW36539, HW36548, HW36549, HW36550, HW36551, HW36552, HW36604, HW36605, HW36606, HW36607, HW36608, HW36639, HW36640, HW36641, HW36645, HW36649, HW36651, HW36661, HW36674, HW36675, HW36676, HW36687, HW36714, HW36729, HW36731, HW36732, HW36733, HW36734, HW36735, HW36737, HW36738, HW36739, HW36744, HW36908, HW36909, HW36922, HW36923, HW36925, HW36932 GTIN 00888707005951, Serial Numbers: HW35279, HW35331, HW35503, HW35524, HW35581, HW35675, HW35715, HW35720, HW35739, HW35768, HW35787, HW35788, HW35789, HW35790, HW35791, HW35792, HW35793, HW35794, HW35795, HW35796, HW35797, HW35798, HW35799, HW35821, HW35822, HW35823, HW35824, HW35825, HW35826, HW35827, HW35831, HW35833, HW35834, HW35835, HW35836, HW35837, HW35838, HW35839, HW35840, HW35841, HW35842, HW35843, HW35844, HW35845, HW35846, HW35883, HW35887, HW35888, HW35889, HW35890, HW35891, HW35892, HW35893, HW35894, HW35895, HW35896, HW35897, HW35898, HW35900, HW35905, HW35906, HW35907, HW35921, HW35925, HW35926, HW35928, HW35930, HW35933, HW35934, HW35945, HW35946, HW35947, HW35948, HW35949, HW35950, HW35951, HW35952, HW35953, HW35954, HW35955, HW35956, HW35957, HW35959, HW35960, HW35961 GTIN 00888707002264, Serial Numbers: HW35741, HW35773 GTIN 00888707006316, Serial Numbers: HW35754, HW35774, HW35865, HW35868, HW35874, HW35940, HW35958, HW35962, HW35963, HW35964, HW35965 GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35819, HW35820, HW35847, HW35848, HW35850, HW35851, HW35852, HW35853, HW35854, HW35855, HW35856, HW35857, HW35858, HW35859, HW35860, HW35861, HW35862, HW35863, HW35864, HW35867, HW35870, HW35875, HW35923, HW35924, HW35927, HW35929, HW35931, HW35935, HW35936, HW35937, HW35938, HW35939, HW35966, HW35967, HW35968, HW35969, HW35970, HW35971, HW35972, HW35973, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997 GTIN 00888707006309, Serial Numbers: HW35876, HW35882, HW35884, HW35885, HW35886, HW35941, HW35942, HW35999 GTIN 00888707006347, Serial Numbers: HW35902, HW35903, HW35908, HW35909, HW35910, HW35911, HW35912, HW35913, HW35914, HW35915, HW35918, HW35920, HW36001, HW36002, HW36003, HW36016, HW36035, HW36036, HW36037, HW36038, HW36039, HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623 GTIN 00888707006446, Serial Numbers: HW35979, HW35980, HW35982, HW35984, HW36160, HW36161, HW36162, HW36163, HW36164, HW36278, HW36287, HW36381, HW36382, HW36383, HW36384, HW36385, HW36386, HW36387, HW36388, HW36460, HW36462, HW36464, HW36465, HW36469, HW36470, HW36471, HW36472, HW36480, HW36481, HW36482, HW36483, HW36484, HW36486, HW36487, HW36489, HW36491, HW36492, HW36494, HW36495 GTIN 00888707006392, Serial Numbers: HW35986, HW35987, HW36066, HW36085, HW36086, HW36213, HW36214, HW36215, HW36216, HW36217, HW36218, HW36219, HW36220, HW36289, HW36311, HW36417, HW36418, HW36517, HW36587, HW36588, HW36589, HW36590, HW36652, HW36656, HW36860 GTIN 00888707007290, Serial Numbers: HW36421, HW36422 GTIN 00888707006354, Serial Numbers: HW36838, HW36880 No GTIN, Serial Numbers: HW26099, HW26126, HW26330, HW26660, HW26939, HW26940, HW27099, HW27452, HW27678, HW28063, HW28199, HW28373, HW28418, HW28895, HW28973, HW29073, HW29214, HW29298, HW29318, HW29351, HW29353, HW29354, HW29359

Product: Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP

GTIN 00888707000697, Serial numbers: HW34700, HW34703, HW34710, HW34713 GTIN 00888707005838, Serial Numbers: HW40383, HW40412, HW40413, HW40414, HW40415, HW40417, HW40418, HW40419, HW40420, HW40421, HW40422, HW40423, HW40424, HW40425, HW40426, HW40428, HW40429, HW40431, HW40465, HW40471, HW40472, HW40473, HW40474, HW40475, HW40476, HW40477, HW40478, HW40479, HW40480, HW40552, HW40553, HW40554, HW40555, HW40556, HW40557, HW40564, HW40565, HW40580, HW40599, HW40600, HW40602, HW40603, HW40604, HW40607, HW40609, HW40611, HW40612, HW40613, HW40649, HW40650, HW40651, HW40652, HW40653, HW40655, HW40656, HW40657, HW40658, HW40659, HW40660, HW40661, HW40662, HW40663, HW40664, HW40666, HW40667, HW40668, HW40789, HW40816, HW40881, HW40950, HW40951, HW40952, HW40953, HW40954, HW40955, HW40956, HW40957, HW40958, HW40960, HW40961, HW41045

Product: Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

All lots and serial numbers in distribution

Product: Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

GTIN 00888707000147, All lot numbers in distribution

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85397
Status: Active
Manufacturer: Heartware, Inc.
Manufactured In: United States
Units Affected: 5 products (2614 units; 2225 Units; 85 units; 20147 devices; 560 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.