Device recall
Z-0221-2020: CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS…
FDA device recall · Class I · Thoratec Switzerland GMBH
Key facts
| Recall number (Z-number) | Z-0221-2020 |
|---|---|
| Recall event | 83895 |
| Product | CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System. |
| Product code | KFM |
| Recalling firm | Thoratec Switzerland GMBH |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 26, 2024 |
| 510(k) numbers | K020271 |
| FEI number | 3003306248 |
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