Device recall
Z-0103-2019: Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag…
FDA device recall · Class II · Thoratec Switzerland GMBH
Key facts
| Recall number (Z-number) | Z-0103-2019 |
|---|---|
| Recall event | 80917 |
| Product | Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System. |
| Product code | KFM |
| Recalling firm | Thoratec Switzerland GMBH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K020271, K083340, K090004, K090051, K131179 |
| 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