Device 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.
Z-2072-2021
Product summary
- Firm
- Heartware, Inc.
- Event
- Event 88135
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2072-2021
Official wording
Reason: The pump has an impeller with a shroud height that did not meet the lower control limit.
Code information: UDI: 00888707007139. Serial Number HW42843
Distribution pattern: International distribution to the country of Germany.
Derived failure modes
-
Unknown
The pump has an impeller with a shroud height that did not meet the lower control limit.