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.
FDA Recall Z-2072-2021 · Posted None
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Recalling FirmHeartware, Inc.
Recall StatusTerminated
Product CodeDSQ
Date Initiated2021-05-28
Date Terminated2026-09-22
Product Quantity1 unit
Reason for Recall
The pump has an impeller with a shroud height that did not meet the lower control limit.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
International distribution to the country of Germany.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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