Recall Z-2072-2021 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
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.
| Date | May 28, 2021 |
| Status | Terminated |
| Reason | The pump has an impeller with a shroud height that did not meet the lower control limit. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1 unit |
| Distribution | International distribution to the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.