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U.S. Department of Health and Human Services

Class 2 Device Recall HVAD Pump Implant Kit

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  Class 2 Device Recall HVAD Pump Implant Kit see related information
Date Initiated by Firm May 28, 2021
Create Date July 13, 2021
Recall Status1 Open3, Classified
Recall Number Z-2072-2021
Recall Event ID 88135
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Code Information UDI: 00888707007139. Serial Number HW42843
Recalling Firm/
Manufacturer		 Heartware, Inc.
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact MCS Customer Service
877-367-4823
Manufacturer Reason
for Recall		 The pump has an impeller with a shroud height that did not meet the lower control limit.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm initiated the recall to the sole consignee on 05/28/2021 by telephone. The consignee was asked to quarantine and return the affected device.
Quantity in Commerce 1 unit
Distribution International distribution to the country of Germany.
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
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