Recall Z-1972-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink re
| Date | Aug 14, 2013 (initiated Jul 16, 2013) |
| Status | Terminated |
| Reason | Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device. |
| Root cause | Nonconforming Material/Component |
| Action | Edwards sent an Urgent Field Safety Notice letter dated July 16, 2013 via Fed-Ex. The letter identified the affected product, problem and action to be taken. The letter included a Customer Acknowledgement Form to be completed and faxed to 800-422-9329 Attn: Recall Coordinator. If the customer does not send back the acknowledgement form, two additional contacts are made to notify the customer and request return of affected product. This is tracked by Edwards customer service and reported each week. Customer were requested to assess their inventory to assure that all affected product is ide |
| Quantity | 855 |
| Distribution | US Nationwide including Canada and VA sites. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA Heartport, Inc., Jun 17, 1997 |