Recall Z-1963-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.
| Date | Aug 14, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. |
| Root cause | Process control |
| Action | Edwards Lifesciences sent a Urgent Field Safety Notice letter dated July 30, 2013, via Fed-Ex to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters are tracked through customer service and as part of the customer acknowledgement letter. Customers are asked to return products. If the customer does not send back the acknowledgement letter, three 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. We reco |
| Quantity | 29,618 units |
| Distribution | Nationwide and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990396 | T-ANASTAFLO Edwards Lifesciences Research Medical, Oct 1, 1999 |