Device recall
Z-1370-2011: MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1…
FDA device recall · Class II · St. Jude Medical Cardiovascular Division
Key facts
| Recall number (Z-number) | Z-1370-2011 |
|---|---|
| Recall event | 57850 |
| Product | MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery. |
| Product code | DWS |
| Recalling firm | St. Jude Medical Cardiovascular Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2012 |
| FEI number | 2182269 |
At a glance
- None 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