Device recall
Z-1131-2015: HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For…
FDA device recall · Class I · HeartWare Inc
Key facts
| Recall number (Z-number) | Z-1131-2015 |
|---|---|
| Recall event | 70340 |
| Product | HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings… |
| Product code | DSQ |
| Recalling firm | HeartWare Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 5, 2020 |
| 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