Recall Z-1306-2025 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR
| Date | Mar 13, 2025 (initiated Feb 5, 2025) |
| Status | Open, Classified |
| Reason | Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible). |
| Root cause | Process control |
| Action | Beginning February 5, 2025, the firm began notifying consignees through a formal Urgent Medical Device Recall letter. Impacted customers were instructed to quarantine and return affected product. ***UPDATE*** Beginning 25 June 2025, Medtronic distributed the Urgent medical Device Recall notice via mail courier to existing and newly identified consignees who have received impacted products. Recall scope was expanded to include additional lots. |
| Quantity | 316,205 |
| Distribution | Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100274 | MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L Medtronic, Inc., May 10, 2010 |