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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

LivaNova USA Inc: This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

Agency Publication Date: January 27, 2020
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Affected Products

Product: Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

Serial numbers 35794, 37762, 37792, 37872, 37874, 37881, 37885, 37889, 37890, 37893, 37913, 37915, 37916, 37965, 37975, 37977, 37984, 37987, 37988, 37990, 38051, 38054, 38068, 38132, 38148, 38153, 38154, 38155, 38162, 38173, 38210, 38224, 38226, 38239, 38240, 38243, 38245, 38246, 38248, 38249, 38252, 38268, 38272, 38273, 38274, 38275, 38277, 38279, 38282, 38284, 38292, 38293, 38296, 38299, 38302, 38306, 38308, 38312, 38314, 38315, 38319, 38321, 38326, 38330, 38344, 38443, 38464, 38490, 38505, 38517, 38529, 38530, 38549, 38561, 38564, 38565, 38625, 38628, 38651, 38661, 38689, 38691, 38698, 38702, 38719, 38722, 38730, 38735, 38745, 38751, 38754, 38755, 38771, 38773, 38775, 38779, 38800, 38804, 38805, 38809, 39334, 39344, 39347, 39354, 39362, and 39731. The expiration date range is 2/25/2017-5/1/2017.

Product: Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

Serial numbers 36519, 36766, 36770, 36776, 36791, 36794, 36800, 36802, 36821, 36824, 36833, 36835, 36845, 36847, 36849, 36869, 36873, 36932, 36935, 36940, 36947, 36951, 36954, 36959, 36961, 36962, 36963, 36964, 36965, 36972, 36981, 36998, 37003, 37014, 37015, 37016, 37024, 37025, 37052, 37095, 37110, 37111, 37116, 37123, 37149, 37151, 37156, 37181, 37213, 37231, 37234, 37239, 37248, 37250, 37253, 37258, 37263, 37270, 37294, 37296, 37297, 37301, 37302, 37310, 37328, 37329, 37331, 37332, 37334, 37338, 37339, 37351, 37353, 37355, 37359, 37360, 37362, 37365, 37371, 37376, 37378, 37383, 37389, 37391, 37395, 37396, 37397, 37402, 37403, 37405, 37409, 37410, 37411, 37414, 37417, 37420, 37421, 37422, 37424, 37425, 37431, 37435, 37439, 37445, 37446, 37449, 37454, 37455, 37458, 37461, 37464, 37466, 37471, 37472, 37480, 37482, 37487, 37488, 37489, 37490, 37498, 37501, 37502, 37505, 37507, 37508, 37510, 37512, 37530, 37540, 37548, 37551, 37559, 37561, 37563, 37564, 37566, 37567, 37572, 37574, 37576, 37577, 37579, 37585, 37587, 37591, 37601, 37607, 37611, 37615, 37634, 37639, 37649, 37662, 37663, 37671, 37672, 37676, 37677, 37678, 37682, 37683, 37689, 37697, 37706, 37708, 37710, 37720, 37723, 37724, 37727, 37730, 37733, 37736, 37738, 37908, 37909, 37920, 37925, 37941, 38091, 38105, 38126, 38212, 38215, 38437, 38446, 38494, 38614, 38657, 38671, 38990, 39025, 39032, 39057, 39068, 39069, 39079, 39261, 39263, 39286, 39340, 39341, 39390, 39412, 39415, 39420, 39421, 39429, 39455, 39463, 39466, 39467, 39470, 39473, 39475, 39477, 39486, 39490, 39499, 39505, 39511, 39532, 39636, 39664, 39906, 39911, 39953, 39970, 40007, 40017, 40036, 40081, 40104, 40116, 40145, 40149, 40159, 40248, 40270, 40280, 40306, 40314, 40320, 40340, 40345, 40346, 40347, 40353, 40355, 40401, 40404, 40426, 40454, 40481, 40482, 40486, 40491, 40492, 40494, 40499, 40503, 40513, 40516, 40517, 40521, 40522, 40528, 40532, 40533, 40534, 40537, 40538, 40540, 40542, 40544, 40551, 40557, 40563, 40565, 40569, 40570, 40572, 40573, 40574, 40582, 40585, 40590, 40591, 40595, 40611, 40619, 40627, 40633, 40640, 40643, 40664, 40676, 40684, 40692, 40694, 40696, 40708, 40718, 40723, 40731, 40736, 40737, 40741, 40750, 40753, 40755, 40757, 40762, 40767, 40769, 40770, 40772, 40774, 40777, 40778, 40780, 40781, 40783, 40784, 40786, 40788, 40789, 40790, 40792, 40793, 40794, 40795, 40801, 40802, 40804, 40808, 40809, 40822, 40823, 40824, 40830, 40834, 40838, 40839, 40840, 40844, 40845, 40846, 40851, 40853, 40854, 40856, 40857, 40861, 40870, 40871, 40873, 40874, 40879, 40881, 40883, 40888, 40894, 40895, 40912, 40919, 40921, 40927, 40934, 40935, 40942, 40943, 40971, 40983, 40993, 41010, 41032, 41039, 41044, 41048, 41051, 41059, 41060, 41065, 41071, 41075, 41078, 41079, 41082, 41083, 41084, 41088, 41090, 41104, 41108, 41113, 41114, 41118, 41120, 41124, 41130, 41133, 41137, 41146, 41148, 41149, 41150, 41157, 41159, 41160, 41169, 41172, 41173, 41178, 41180, 41182, 41195, 41196, 41199, 41200, 41202, 41207, 41209, 41229, 41240, 41246, 41249, 41250, 41253, 41254, 41255, 41264, 41266, 41271, 41283, 41290, 41299, 41301, 41320, 41321, 41322, 41323, 41324, 41326, 41327, 41328, 41347, 41348, 41351, 41354, 41357, 41359, 41368, 41370, 41374, 41380, 41390, 41394, 41413, 41422, 41468, 41470, 41472, 41483, 41487, 41488, 41496, 41506, 41508, 41517, 41519, 41524, 41540, 41547, 41552, 41555, 41559, 41569, 41577, 41589, 41594, 41598, 41601, 41609, 41612, 41617, 41626, 41627, 41629, 41637, 41640, 41645, 41654, 41656, 41661, 41663, 41665, 41671, 41673, 41692, 41696, 41700, 41706, 41740, 41749, 41753, 41756, 41759, 41768, 41773, 41776, 41779, 41791, 41823, 41832, 41833, 41840, 41852, 41872, 41874, 41875, 41879, 41881, 41885, 41905, 41907, 41911, 41926, 41929, 41931, 41932, 41933, 41936, 41943, 41944, 41946, 41953, 41957, 41973, 41979, 42005, 42021, 42036, 42043, 42046, 42051, 42069, 42133, 42134, 42144, 42150, 42154, 42155, 42160, 42177, 42181, 42182, 42186, 42199, 42202, 42219, 42220, 42223, 42224, 42225, 42233, 42234, 42242, 42247, 42255, 42259, 42267, 42268, 42269, 42274, 42292, 42316, 42326, 42336, 42347, 42353, 42354, 42356, 42361, 42387, 42391, 42392, 42405, 42415, 42417, 42428, 42466, 42504, 42505, 42514, 42523, 42528, 42529, 42537, 42539, 42565, 42567, 42568, 42571, 42572, 42579, 42587, 42588, 42592, 42593, 42594, 42595, 42599, 42600, 42601, 42605, 42606, 42608, 42610, 42611, 42613, 42615, 42619, 42624, 42625, 42627, 42629, 42631, 42632, 42633, 42634, 42635, 42636, 42641, 42642, 42643, 42644, 42645, 42647, 42654, 42657, 42658, 42659, 42664, 42666, 42667, 42681, 42685, 42689, 42696, 42697, 42698, 42702, 42703, 42706, 42711, 42713, 42718, 42719, 42720, 42721, 42722, 42725, 42727, 42733, 42735, 42738, 42739, 42746, 42747, 42750, 42754, 42756, 42758, 42761, 42763, 42767, 42773, 42776, 42778, 42781, 42784, 42785, 42787, 42788, 42789, 42811, 42820, 42834, 42835, 42839, 42840, 42844, 42847, 42861, 42862, 42865, 42866, 42868, 42869, 42871, 42873, 42876, 42877, 42880, 42881, 42887, 42888, 42890, 42892, 42893, 42895, 42900, 42902, 42920, 42934, 42945, 42962, 43003, 43012, 43025, 43031, 43032, 43038, 43095, 43102, 43103, 43107, 43109, 43115, 43118, 43129, 43136, 43140, 43144, 43151, 43157, 43165, 43167, 43169, 43172, 43177, 43178, and 43201. The expiration date range is 9/30/2016-2/28/2017.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84029
Status: Resolved
Manufacturer: LivaNova USA Inc
Manufactured In: United States
Units Affected: 2 products (106 devices; 745 devices)

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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

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