Recall Z-0306-05 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences Research Medical Inc
EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
| Date | Dec 15, 2004 (initiated Nov 19, 2004) |
| Status | Terminated |
| Reason | Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery. |
| Root cause | Other |
| Action | All consignees were notified by letter on 11/22/2004 |
| Quantity | 396 units |
| Distribution | AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020693 | AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 Embol-X, Inc., Sep 5, 2002 |