Device recall
Z-0582-2019: Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US…
FDA device recall · Class II · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-0582-2019 |
|---|---|
| Recall event | 81609 |
| Product | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to… |
| Product code | DSQ |
| Recalling firm | Heartware, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 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