Device recall
Z-1887-2016: HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx…
FDA device recall · Class I · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-1887-2016 |
|---|---|
| Recall event | 73636 |
| Product | HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The… |
| Product code | DSQ |
| Recalling firm | Heartware, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 27, 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