Device recall
Z-1266-2022: HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular…
FDA device recall · Class I · Medtronic Inc
Key facts
| Recall number (Z-number) | Z-1266-2022 |
|---|---|
| Recall event | 90228 |
| Product | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System. |
| Product code | DSQ |
| Recalling firm | Medtronic Inc |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P100047 |
| FEI number | 3001504994 |
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