Recall Z-0535-2018 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
| Date | Jan 30, 2018 (initiated Jan 3, 2018) |
| Status | Terminated |
| Reason | Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve. |
| Root cause | Component change control |
| Action | In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned. |
| Quantity | 2914 units |
| Distribution | DE, IA, CA and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171308 | Tubing Pack Medtronic, Inc., Jun 2, 2017 |