Device recall
Z-0634-04: ATS Open Pivot Mechanical Heart Valve
FDA device recall · Class II · ATS Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0634-04 |
|---|---|
| Recall event | 28356 |
| Product | ATS Open Pivot Mechanical Heart Valve |
| Product code | LWQ |
| Recalling firm | ATS Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2005 |
| PMA numbers | P990046 |
| FEI number | 3008592544 |
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