Medtronic Inc Recall 86924
Description: Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103 b. PUMP 1104 c. PUMP 1104JP
Medtronic Inc Recall 86924 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0946-2021 |
| Event ID | 86924 |
| Event Description | Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103 b. PUMP 1104 c. PUMP 1104JP |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide |
| Quantity | 386 units |
| Recall Reason | Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population. |
| Device Classification | 20210210 |
| Device Code Info | a. Model Number 1103: GTIN 00888707003261, Serial Numbers HW40727, HW40793, HW40806, HW40213, HW40196, HW40067, HW40462, HW40773, HW40793, HW40045, HW40892, HW40498, HW40732, HW40091, HW40806, HW40124, HW40172, HW40748, HW40762, HW40287, HW40751, HW40115, HW40714, HW40229, HW40822, HW40779, HW40161, HW40469, HW40756, HW40785, HW40695, HW40869, HW40137, HW40054, HW40234, HW40764, HW40169, HW40438, HW40791, HW40781, HW40767, HW40775, HW40795, HW40860, HW40711 GTIN 00888707002639, Serial Numbers: HW31591, HW30943, HW32328, HW32330, HW31534, HW32425, HW31203, HW31459, HW31189, HW30940, HW30753, HW31611, HW32344, hw31035, HW31222, HW29952, HW31041, HW31169, HW31118, HW35448, HW31199, HW31180, HW30659, HW31207, HW31327, HW31102, HW31163, HW30942, HW31497, HW32322, HW32421, HW31368, HW32284, HW31403, HW30760, HW32333, HW32251, HW31116, HW31474, HW32119, HW30785, HW31245, HW31191, HW35286, HW31623, HW35245, HW31481, HW32266, HW30677, HW31038, HW31126, HW35006, HW30790, HW30553, HW31238, HW32450, HW35224, HW35430, HW31149, HW31217, HW31160, HW30991, HW31055, HW30895, HW31652, HW31468, hw31099, HW35425, HW31765, HW32403, HW31613, HW32439, HW31247, HW31131, HW30701, HW31043, HW31344, HW30554, HW34942, HW31237, HW31212, HW31007, HW31172, HW31395, HW31317, HW30641, HW31206, HW32307, HW32362, hw31003, HW31059, HW31184, HW31570, HW31181, HW32302, HW32417, HW31463, HW30745, HW31078, HW31271, HW31330, HW31561, HW31568, HW30481, HW30550, HW30777, HW31067, hw31086, HW31328, HW31785, HW32312, HW32329, HW31477, HW31610, HW31139 b. Model Number 1104 PUMP 1104 HVAD IMPLANT KIT EN ZH, GTIN 00888707000239, Serial Numbers: HW30877 PUMP 1104 HVAD IMPLANT KIT EN DE TR, GTIN 00888707000581, Serial Numbers: HW31187, HW31144 PUMP 1104 HVAD IMPLANT KIT EN FR, GTIN 00888707000680, Serial Numbers: HW31145 PUMP 1104 HVAD 2.0 IMPLANT KIT EN, GTIN 00888707001649, Serial Numbers: HW35547, hw29653, hw31133, HW35365, HW35418, HW31009, HW31014, HW35408, HW35558, hw30803, HW30840, hw31515, HW35314, HW35409, HW30738, HW32264, HW35338, HW29362, HW30741, HW30838, HW30939, HW34932, HW35329, HW35559, HW35662, HW31018, HW31063, HW35333, HW35328, HW31071, HW31554, HW35411, HW30862, HW31092, HW31587, HW35309, HW35315, hw31505, HW34936, HW35476, hw31510, HW35021 PUMP 1104 HVAD 2.0 IMPLANT KIT DE, GTIN 00888707002028, Serial Numbers: HW31219, HW31254, HW30813, HW31242, HW31544, HW31549, HW31559, HW31731, HW35584, HW35702, HW35707, HW30809, HW30966, HW31226, HW31571, HW35674, HW30954, HW31228, HW31402, hw31454, HW35629, HW30771, HW31244, HW32260, HW30970, HW31111, HW31261, HW30768, HW30769, HW31114, HW31579, HW32499, HW35305, HW35332, HW35692, HW35696, hw31451, HW31235, HW31255, HW31543, HW35669, HW30967, HW31251, HW31398, HW31541, HW32468, HW31076, HW31192, HW35334, HW31550 PUMP 1104 HVAD2.0 IMPLANT KIT FR, GTIN 00888707002387, Serial Numbers: HW31075, HW31555, HW31095, HW31161, HW31077, HW31348, HW34006, HW31080 PUMP 1104 HVAD 2.0 IMPLANT KIT IT, GTIN 00888707002394, Serial Numbers: HW31580, HW35336, HW35484 PUMP 1104 HVAD 2.0 IMPLANT KIT NO, GTIN 00888707002417, Serial Numbers: HW35756 PUMP 1104 HVAD 2.0 IMPLANT KIT SV, GTIN 00888707002424, Serial Numbers: HW30766 PUMP 1104 HVAD 2.0 IMPLANT KIT CS, GTIN 00888707002431, Serial Numbers: hw31123 PUMP 1104 HVAD 2.0 IMPLANT KIT SK, GTIN 00888707002448, Serial Numbers: HW35398 PUMP 1104 HVAD 2.0 IMPLANT KIT TR, GTIN 00888707002486, Serial Numbers: HW30793, HW30794, HW30798, HW30800, HW30848, hw30981, hw30982, hw31100, hw31110, hw31112, hw31137, hw31138, HW31430, HW31444, HW34954, HW35228, HW35278, HW35297, HW35298, HW35300, HW35303, HW35614, HW35746 PUMP 1104 HVAD 2.0 IMPLANT KIT NL, GTIN 00888707002493, Serial Numbers: hw31173, HW35346, hw30984, HW31096, hw31164, HW35158, HW35401, HW31520, HW35574 PUMP 1104 HVAD 2.0 IMPLANT KIT EL, GTIN 00888707002516, Serial Numbers: hw31146, hw31147, hw31162 PUMP 1104 HVAD 2.0 IMPLANT KIT PL, GTIN 00888707002523, Serial Numbers: hw31129 PUMP 1104 HVAD 2.0 IMPLANT KIT ES, GTIN 00888707002530, Serial Numbers: HW30797, HW35162, HW35590 PUMP 1104 HVAD IMPLANT KIT EN FR 2.0, GTIN 00888707002547, Serial Numbers: HW31141, HW31156, HW31158, HW31416, HW31429, HW30593, HW30783, HW30826, HW32309 PUMP 1104 HVAD IMPLANT KIT KO, 00888707002554, Serial Numbers: HW35772 PUMP 1104 HVAD 2.0 IMPLANT KIT RU, GTIN 00888707002585, Serial Numbers: hw31079, hw31081, hw31168, HW35497, HW35575, HW30834, HW35095, HW35351 PUMP 1104 HVAD IMPLANT KIT EN, GTIN 00888707005951, Serial Numbers: HW35837, HW35895, HW35788, HW35897, HW35948, HW35795, HW35822, HW35960, HW35949, HW35930, HW35581, HW35846, HW35954, HW35797, HW35955, HW35823, HW35961, HW35503 PUMP 1104 HVAD IMPLANT KIT DE, GTIN 00888707005968, Serial Numbers: HW35807, HW35973, HW35819, HW35939, HW35969, HW35996, HW35875, HW35806, HW35978, HW35859, HW35814, HW35975 PUMP 1104 HVAD IMPLANT KIT CA, GTIN 00888707006019, Serial Numbers: HW36057, HW35377, HW36167 PUMP 1104 HVAD IMPLANT KIT IT, GTIN 00888707006309, Serial Numbers: HW35885 PUMP 1104 HVAD IMPLANT KIT FR, GTIN 00888707006316, Serial Numbers: HW35958, HW35965 PUMP 1104 HVAD IMPLANT KIT EN, GTIN 00888707006323, Serial Numbers: HW35391, HW36030, HW36242, HW35382, HW36210, HW36032, HW35977, HW35389 PUMP 1104 HVAD IMPLANT KIT DE, GTIN 00888707006330, Serial Numbers: HW35396, HW36175, HW35769 PUMP 1104 HVAD IMPLANT KIT TR, GTIN 00888707006347, Serial Numbers: HW35915, HW36103, HW36106 PUMP 1104 HVAD IMPLANT KIT IT, GTIN 00888707006392, Serial Numbers: HW35987 PUMP 1104 HVAD IMPLANT KIT FR, GTIN 00888707006408, Serial Numbers: HW35932 PUMP 1104 HVAD IMPLANT KIT KO, GTIN 00888707006446, Serial Numbers: HW35984, HW36162 PUMP 1104 HVAD IMPLANT KIT CA, GTIN 00888707007290, Serial Numbers: HW35919 1104 - HVAD Pump Implant Kit: Sintered (OUS), No GTIN available, Serial Numbers: HW30791 c. Model 1104JP PUMP 1104 HVAD IMPLANT KIT EN JA, GTIN 00888707005838, Serial Numbers: HW40418, HW40479, HW40660, HW40429, HW40477 |
| Center Classification Date | 20210204 |
| Recall Initiation Date | 20201119 |
| Recalling Firm | Medtronic Inc |
| Initial Notification | Visit |
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