Recall Z-2420-2015 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
| Date | Aug 19, 2015 (initiated Jul 24, 2015) |
| Status | Terminated |
| Reason | EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. |
| Root cause | Packaging process control |
| Action | On July 24, 2015 Medtronic sales representatives began verbally notifying the customers of the issue, requesting quarantine and return of un-used, affected product Consignees were sent a Medtronic "Urgent Medical device Recall" letter dated August 2015. The letter was addressed to Risk Manger and Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to quarantine and remove the product from their inventory and return it to Medtronic. Requested consignees to complete and return the Customer Confirmation Certificate via email to |
| Quantity | 221 (111 US, 110 OUS) |
| Distribution | Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031037 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE Medtronic Perfusion Systems, May 13, 2003 |