Recall Z-2739-2026 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
| Date | Jul 15, 2026 (initiated May 25, 2026) |
| Status | Open, Classified |
| Reason | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. |
| Root cause | Packaging |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 6/4/2026 via courier. The notice explained the problem, potential risk, and requested the product be discarded in a clearly marked biohazard bag or container and discarded. Consignees were directed to complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com and contact Medtronic Customer Service at 1-800-854-3570, Option 1 then Option 4, and reference this communication to initiate to arrange for credit or replacement product. Consignees were requested to share within their organiz |
| Distribution | Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153598 | Medtronic Bio-Medicus Adult Cannula Kit Medtronic, Inc., Jan 15, 2016 |