Device recall
Z-0126-2024: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA device recall · Class II · SynCardia Systems LLC
Key facts
| Recall number (Z-number) | Z-0126-2024 |
|---|---|
| Recall event | 92930 |
| Product | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO |
| Product code | LOZ |
| Recalling firm | SynCardia Systems LLC |
| Recall class | Class II |
| Status | Completed |
| PMA numbers | P030011 |
| FEI number | 3003761017 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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