Recall Z-0985-2025 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
| Date | Jan 17, 2025 (initiated Dec 12, 2024) |
| Status | Open, Classified |
| Reason | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. |
| Root cause | Packaging |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 12/12/24 was sent to customers. Patient Recommendations: Patients previously supported with an impacted device face no additional risk from the issue described in this communication and should continue to be monitored per your practice s normal follow-up procedures. Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " Return unused, listed product in your inventory to Medtronic by cont |
| Quantity | 930 units |
| Distribution | Worldwide - US Nationwide distribution. |
| 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 |