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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

Terumo Cardiovascular Systems Corporation: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications; During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

Agency Publication Date: July 23, 2014
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Affected Products

Product: Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0673777; Part No. 4344, Lot #: 0645166, 0653856, 0673024; Part No. 9485, Lot #: 654068; Part No. 9486, Lot #: 649867; Part No. 4400, Lot #: 0650491, 0659436, 0669133, 0674461; Part No. 165267, Lot #: 0654562, 0672209, 0676284, 0678213; Part No. 165266, Lot #: 0658973, 0661133, 0667798, 0675018, 0678084; Part No. 9483, Lot #: 0649709, 0653442, 0655043; Part No. 4460, Lot #: 0667803, 0675761, 0677655; Part No. 165765, Lot #: 677007; Part No. 165265, Lot #: 0652644, 0659820, 0674746, 0683956; Part No. 165264, Lot #: 0646481, 0650489, 0653235, 0668894, 0676282, 0681876, 0683955 & Part No. 9484, Lot #: 0649158, 0655040, 0660676.

Lot Numbers:
0649648
0653227
0645166
654068
649867
0650491
0654562
0658973
0649709
0667803
677007
0652644
0646481
0649158
Product: Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

, Part No. 144936, Lot #: 653821

Lot Numbers:
653821
Product: Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

Part No. 4934, Lot #: 0655207, 0657317, 0666535, 0682313, 0697852; Part No. 4934X, Lot #: 0659445, 0696672; Part No. 4935, Lot #: 0655206, 0656923, 0682315, 0685669, 0696718; Part No. 4936, Lot #: 0655292, 0665320, 0684443, 0684444, 0687492, 690459R & Part No. 4936X, Lot #: 0656438, 0661606, 683308R.

Lot Numbers:
0655207
0659445
0655206
0655292
0656438
Product: Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

Part No. 4881, Lot #: 0646527, 0652247, 0655237, 0657761, 0659431, 0663547, 0666625, 0674022, 0676975, 0678722, 0681793, 0693318, 0695683, 0697379; Part No. 4881X, Lot #: 684032; Part No. 4882, Lot #: 0646526, 0649165, 0650782, 0653857, 0657248, 0662811, 0668349, 0673863, 0676584, 0678953, 0682571, 0683601, 683601R; Part No. 4882X, Lot #: 0651693, 0656946, 0668566, 0683306, 683306R; Part No. 4883, Lot #: 0647472, 0653433, 0658525, 0659432, 0662541, 0673755, 0676593, 0681816, 0691567, 0696613; Part No. 4883X, Lot #: 0649154, 0653823, 0675680; Part No. 4884, Lot #: 0646143, 0647046, 0649882, 0652246, 0654605, 0662807, 0667262, 0670484, 0674103, 0677804, 0683383, 0683605, 0692771, 0696611; Part No. 4884X, Lot #: 0649169, 0653445, 0683608; Part No. 4885, Lot #: 0647474, 0652803, 0655236, 0662804, 0670673, 0675804, 0677976, 0681127, 0695872, 0698980; Part No. 4885X, Lot #: 0652526, 0662887; Part No. 4886, Lot #: 0659433, 0661555, 0667893, 0669797, 0681817; Part No. 4886X, Lot #: 652528 & Part No. 4887, Lot #: 0661530, 0668567, 0672138.

Lot Numbers:
0646527
684032
0646526
0651693
0647472
0649154
0646143
0649169
0647474
0652526
0659433
652528
0661530
Product: Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Part No. 16094, Lot #: 655235

Lot Numbers:
655235
Product: Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585, 0678728, 0681792, 0684780, 0685667, 0688001, 0691202, 0693823, 0694711, 0696205, 0698300, 0708186, 0708766, 0710058, 0711914, 0714958, 0716134, 0717932, 0719278, 0721688, 694711R, 696201R; Part No. 4949, Lot #: 0646532, 0650731, 0651656, 0652458, 0655167, 0659823, 0661134, 0666626, 0667247, 0668568, 0669798, 0672411, 0675022, 0677305, 0677868, 0678727, 0681772, 0683304, 0683963, 0685668, 0687773, 0688994, 0694411, 0694706, 0695244, 0698301, 0703802, 0708185, 0708765, 0710054, 0711276, 0715262, 0716637, 0718634, 0720571, 695244R, 696204R; Part No. 4949X, Lot #: 0645381, 0653211, 0661604, 0667107, 0669928, 0684001, 0694715, 0712872, 694715R; Part No. 4950, Lot #: 0648462, 0650495, 0656442, 0657280, 0660743, 0674021, 0678721, 0681807, 0684779, 0687498, 0689723, 0693829, 0698851, 0708778, 0710056, 0711836, 0713283, 0719706, 693829R, 695465R; Part No. 4951, Lot #: 0645876, 0649394, 0653430, 0660668, 0661526, 0667894, 0668979, 0674463, 0675778, 0677306, 0678217, 0681808, 0686128, 0687960, 0694412, 0696144, 0696612, 0698299, 0702118, 0708768, 0710037, 0711275, 0713301, 0722066, 696144R & Part No. 4951X, Lot #: 0668569, 0677303, 0696145, 0712873, 696145R.

Lot Numbers:
0646471
0646532
0645381
0648462
0645876
0668569
Product: Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

Part No. 4442, Lot #:, 0646528, 0649147, 0649840, 0654076, 0662223, 0678729; Part No. 14992, Lot #: 0646475, 0649160, 0655317, 0659466, 0666649, 0672081, 0675675, 0681806, 0686885; Part No. 4443, Lot #: 0649883, 0660672 & Part No. 15949, Lot #: 0646530, 0661896, 0667259, 0674784, 0683631.

Lot Numbers:
0646475
0649883
0646530
Product: Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

Part No. 4440, Lot #: 0646496, 0650492, 0659856, 0666657, 0674751, 0677190, 0686887, 0690546; Part No. 164525, Lot #: 0646401, 0652209, 0656640, 0662516, 0674459, 0678212

Lot Numbers:
0646496
0646401
Product: Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava

Part No. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579, Lot #: AM001313, AM007311, AM007721, AM009067, AM016176, AM016523, AM018165; Part No. 813582, Lot #: AM001293, AM017320; Part No. 813581, Lot #: AM002694, AM003543, AM006059, AM017959; Part No. 813584, Lot #: AM001311, AM002688, AM002730, AM006055, AM016188, AM016639; Part No. 813583, Lot #: AM002729, AM006054, AM016187, AM016638, AM018071; Part No. 813586, Lot #: AM001303, AM005726, AM006061, AM008349; Part No. 813585, Lot #: AM002473, AM002728, AM006056, AM010935, AM017208; Part No. 813588, Lot #: AM002690, AM002699, AM003781, AM004252, AM006058, AM008238, AM016477; Part No. 813587, Lot #: AM001314, AM002687, AM003782, AM006057, AM008237, AM016189, AM016476, AM018297; Part No. 813590, Lot #: AM016920 & Part No. 813589, Lot #: AM002720, AM004287.

Lot Numbers:
AM004245
AM001313
AM001293
AM002694
AM001311
AM002729
AM001303
AM002473
AM002690
AM001314
AM016920
AM002720
Product: Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava

Part No. 813542, Lot #: AM000378; Part No. 813541, Lot #: AM002689; Part No. 813544, Lot #: AM006016, AM017817; Part No. 813546, Lot #: AM002709, AM006018, AM006048, AM017262; Part No. 813545, Lot #: AM002705, AM006046, AM007636; Part No. 813548, Lot #: AM002707, AM006050, AM017681; Part No. 813547, Lot #: AM002697, AM006020, AM007724; Part No. 813550, Lot #: AM001312, AM004268, AM007732, AM018316; Part No. 813549, Lot #: AM002717, AM006052, AM007637; Part No. 813552, Lot #: AM003778, AM007725; Part No. 813554, Lot #: AM001309; Part No. 813551, Lot #: AM002702, AM007635; Part No. 813553, Lot #: AM002708; Part No. 813556, Lot #: AM007733; Part No. 813555, Lot #: AM002719; Part No. 813557, Lot #: AM007726; Part No. 813560, Lot #: AM018160; Part No. 813559, Lot #: AM008235; Part No. 813561, Lot #: AM007639; Part No. 813566, Lot #: AM004227, AM017924 & Part No. 813565, Lot #: AM001315, AM006072.

Lot Numbers:
AM000378
AM002689
AM006016
AM002709
AM002705
AM002707
AM002697
AM001312
AM002717
AM003778
AM001309
AM002702
AM002708
AM007733
AM002719
AM007726
AM018160
AM008235
AM007639
AM004227
AM001315
Product: Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

28 Fr with 3/8" flare , Part No., 816460, Lot #:, 0645280, 0649157, 0654734, 0666686, 0674810, 0678724, 0682221, 0684790, 0698319, 0698910; 30 Fr with 3/8" connector , Part No., 820732, Lot #:, 646450 & 30 Fr with 3/8" flare , Part No., 820731, Lot #:, 0689843, 0698323

Product: Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Part No. 7071, Lot #: 0658575, 0662312, 0666660, 0670324, 0670948, 0682566, 0686889, 0689725, 0695466, 0702123, 689725R; Part No. 7072, Lot #: 0658572, 0662311, 0670325, 0686126, 0687466, 0694421, 0702124, 694421R, 694445R; Part No. 7072X, Lot #: 0662871, 662871R, 684785R; Part No. 7080, Lot #: 0661085, 0670671, 0675676, 0687168, 0694423, 0696700, 0702127, 0711833, 694423R; Part No. 5767, Lot #: 0652211, 0661105, 0664361, 0670323, 0675826, 0677192, 0684996, 0685122, 0685123, 0689787, 0697471, 0708188, 0708770, 667914N, 689787R, 695467R; Part No. 5761, Lot #: 0650494, 0653427, 0661106, 0667066, 0668960, 0670940, 0672074, 0677795, 0678216, 0683309, 0685666, 0687798, 0689724, 0694428, 0696206, 0698338, 0703836, 0704646, 0708187, 0708767, 694428R; Part No. 5761X, Lot #: 0653824, 0660674, 0668570, 0674464, 0683051, 0686891, 686891R; Part No. 5767X, Lot #: 0662430, 0670967, 670967R; Part No. 6392, Lot #: 0648090, 0653418, 0659107, 0661101, 0664539, 0676371, 0677191, 0677794, 0685662, 0685663, 0685664, 0689718, 685664R, 689718R, 697473R; Part No. 6394, Lot #: 0650838, 0659106, 0661098, 0670945, 0674474, 0678011, 0685489, 0689720, 0696207, 0702122, 689720R; Part No. 5842, Lot #: 0654074, 0656644, 0671750, 0681809, 0688003, 0695986, 0710040, 688003R; Part No. 5798, Lot #: 0649217, 0656439, 0660663, 0662070, 0670425, 0677301, 0686890, 0688490, 0711274, 0711827, 688490R; Part No. 6393, Lot #: 684774R; Part No. 5768, Lot #: 0649874, 0654075, 0659017, 0662733, 0669800, 0670941, 0675738, 0677971, 0685665, 0687801, 0695468, 0708190, 687801R; Part No. 5762, Lot #: 0647163, 0650493, 0653424, 0659018, 0668571, 0670937, 0673175, 0674263, 0677300, 0678059, 0686324, 0689721, 0694413, 0702121, 0708189, 0708776, 694413R, 696147R; Part No. 5762X, Lot #: 0649168, 0661605, 696146R; Part No. 5768X, Lot #: 0661175, 0673743, 0677012, 677012R, 695469R; Part No. 6384, Lot #: 0649216, 0658580, 0666662, 0670943, 0674472, 0680716, 0687537, 0709686; Part No. 6386, Lot #: 0649585, 0653419, 0666613, 0668004, 0670938, 0676537, 0681103, 0687538, 0688901, 0709688, 688901R; Part No. 5843, Lot #: 0658532, 0677970, 0683959, 0687467, 0701580, 0710041, 687467R, 691572R. Part No. 5841, Lot #: 0660648, 0674761, 0677302, 0702132, 0711246, 690085R; Part No. 6387, Lot #: 0660256, 0695470, 660256R & Part No. 6385, Lot #: 653813.

Lot Numbers:
0658575
0658572
0662871
0661085
0652211
0650494
0653824
0662430
0648090
0650838
0654074
0649217
684774R
0649874
0647163
0649168
0661175
0649216
0649585
0658532
0660648
0660256
653813
Product: CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

Part No. 80003-02, Lot #: PG11, QC11, QL09 & Part No. 80002-03, Lot #: PG11, QL09

Lot Numbers:
PG11
PG11

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68404
Status: Resolved
Manufacturer: Terumo Cardiovascular Systems Corporation
Manufactured In: United States
Units Affected: 13 products (7,460 units; 120 units; 7,190 units; 32,880 units; 20 units; 135,340 units; 6,720 units; 3,040 units; 34,470 units; 14,380 units; 2,290 units; 132, 250 units; 125 units)

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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

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.