Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall HeartWare HVAD System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall HeartWare HVAD System see related information
Date Initiated by Firm November 19, 2020
Date Posted February 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-0946-2021
Recall Event ID 86924
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product Medtronic HVAD Pump Implant Kits, labeled as:
a. PUMP 1103
b. PUMP 1104
c. PUMP 1104JP
Code Information 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 
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
For Additional Information Contact MCS Customer Service
877-367-4823
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action During the week of 19-Nov-2020, Medtronic initiated global retrieval activities for 9 devices for consignees in possession of non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product based on serial number, or the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm followed this action with a letter disseminated on 12/04/2020. In the United States, beginning 18-Dec-2020, Medtronic initiated written consignee communications via UPS 2-day delivery to VAD Coordinators and following physicians identified as having affected product and/or patients with an implanted device in the affected population. In the United States, beginning 23-Dec-2020, Medtronic is also initiating written communication, via UPS 2-day delivery, to inform all accounts who have previously purchased a Medtronic HVAD Pump of the issue. Update 06/01/2022: In the United States, beginning 18-May-2022, Medtronic initiated a verbal communication to update physicians who follow patients that are implanted with a HVAD pump from the subset of devices with a higher rate of failing to restart (first communicated in Dec 2020) that controllers with an unapproved software algorithm that may assist in restarting the HVAD pump and will be made available to sites to use, in the event a standard controller does not restart the pump after a pump is stopped. Medtronic followed up with a written communication via two day tracked mailing on 01-Jun-2022. Following physicians are asked to confirm receipt of the written communication. Medtronic posted the associated Product Performance Advisory on Medtronic.com (https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-update-june-2022.pdf), as a June 2022 Update to December 2020: HeartWare Ventricular Assist Device (HVAD).
Quantity in Commerce 386 units
Distribution Worldwide - US Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
-
-