Device recall
Z-1763-2022: TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model…
FDA device recall · Class I · Cardiac Assist, Inc
Key facts
| Recall number (Z-number) | Z-1763-2022 |
|---|---|
| Recall event | 90755 |
| Product | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass. |
| Product code | DWA |
| Recalling firm | Cardiac Assist, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 8, 2023 |
| 510(k) numbers | K183623 |
| FEI number | 3002228812 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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