Heartware, Inc. Recall 88135
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.
Heartware, Inc. Recall 88135 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2072-2021 |
| Event ID | 88135 |
| Event 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. |
| Product Type | Devices |
| Distribution | International distribution to the country of Germany. |
| Quantity | 1 unit |
| Recall Reason | The pump has an impeller with a shroud height that did not meet the lower control limit. |
| Device Classification | 20210721 |
| Device Code Info | UDI: 00888707007139. Serial Number HW42843 |
| Center Classification Date | 20210713 |
| Recall Initiation Date | 20210528 |
| Recalling Firm | Heartware, Inc. |
| Initial Notification | Telephone |
| Similar To |