Recall Z-0085-2010 ยท DXC Clamp, Vascular
Edwards Lifesciences Research Medical, Inc.
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 in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta,
| Date | Nov 6, 2009 (initiated Sep 24, 2009) |
| Status | Terminated |
| Reason | Spontaneous balloon rupture during use of the product. |
| Root cause | Process control |
| Action | Customers were notified by an Urgent - Product Recall letter, dated 9/29/09, and instructed to check their inventory, identify any unused product and return it to the company. Customers are to contact Customer Service Organization at 1-800-424-3278 to obtain a Returned Goods Authorization number, information concerning replacement product, and if they have any questions. |
| Quantity | 2,737 total |
| Distribution | Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand. |
| FDA record | Open on fda.gov |