Device recall
Z-2072-2021: HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for…
FDA device recall · Class II · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-2072-2021 |
|---|---|
| Recall event | 88135 |
| 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… |
| Product code | DSQ |
| Recalling firm | Heartware, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2026 |
| PMA numbers | P100047 |
| FEI number | 3007042319 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database