Device recall
Z-0659-2017: 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total…
FDA device recall · Class I · SynCardia Systems Inc.
Key facts
| Recall number (Z-number) | Z-0659-2017 |
|---|---|
| Recall event | 75600 |
| Product | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 |
| Product code | LOZ |
| Recalling firm | SynCardia Systems Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 21, 2017 |
| 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