Device recall
Z-0644-2009: Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF…
FDA device recall · Class II · Edwards Lifesciences Research Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0644-2009 |
|---|---|
| Recall event | 50502 |
| Product | Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and… |
| Product code | DXC |
| Recalling firm | Edwards Lifesciences Research Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2011 |
| 510(k) numbers | K964161 |
| FEI number | 1713910 |
At a glance
- 1–9 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