Recall Z-0645-2009 ยท DXC Clamp, Vascular
Edwards Lifesciences Research Medical, Inc.
CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen al
| Date | Jan 5, 2009 (initiated Nov 26, 2008) |
| Status | Terminated |
| Reason | Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173. |
| Root cause | Nonconforming Material/Component |
| Action | All consignees were notified by letter on 11/26/2008 and requested to return any unused product to Edwards. The letter was entitled "PRODUCT RECALL." Questions could be referred to the Edwards representative or call 800-424-3278. |
| Quantity | 963 units |
| Distribution | Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964161 | HEARTPORT ENDOAORTIC CLAMP Heartport, Inc., Apr 4, 1997 |