Z-2072-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- May 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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.
Reason for Recall
The pump has an impeller with a shroud height that did not meet the lower control limit.
Distribution Pattern
International distribution to the country of Germany.
Code Information
UDI: 00888707007139. Serial Number HW42843