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.
This recall is currently active, issued May 28, 2021. It was issued by Heartware, Inc..
- Company
- Heartware, Inc.
- Recall Initiated
- May 28, 2021
- Recall Number
- Z-2072-2021
- Quantity
- 1 unit
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The pump has an impeller with a shroud height that did not meet the lower control limit.
Distribution
International distribution to the country of Germany.
Lot / Code Info
UDI: 00888707007139. Serial Number HW42843
Root Cause
Nonconforming Material/Component
Action Taken
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.