Device recall
Z-0085-2010: EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic…
FDA device recall · Class I · Edwards Lifesciences Research Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0085-2010 |
|---|---|
| Recall event | 53576 |
| Product | EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use… |
| Product code | DXC |
| Recalling firm | Edwards Lifesciences Research Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| 510(k) numbers | K955132, K962510, K964161, K974175 |
| 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