Device recall
Z-2731-2015: Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF…
FDA device recall · Class I · SynCardia Systems Inc.
Key facts
| Recall number (Z-number) | Z-2731-2015 |
|---|---|
| Recall event | 71905 |
| Product | Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular… |
| Product code | LOZ |
| Recalling firm | SynCardia Systems Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 4, 2015 |
| 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