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.
- Company
- Heartware, Inc.
- Recall Initiated
- May 28, 2021
- Recall Number
- Z-2072-2021
- Quantity
- 1 unit
- Firm Location
- Miami Lakes, FL
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.