Device recall
Z-2215-2024: 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411…
FDA device recall · Class II · Thoratec Switzerland GMBH
Key facts
| Recall number (Z-number) | Z-2215-2024 |
|---|---|
| Recall event | 94588 |
| Product | 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System |
| Product code | DSQ |
| Recalling firm | Thoratec Switzerland GMBH |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P170038 |
| FEI number | 3003306248 |
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