Recall Z-2219-2026 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
| Date | May 20, 2026 (initiated Apr 21, 2026) |
| Status | Open, Classified |
| Reason | Certain lots of product have the potential for a sterile barrier breach. |
| Root cause | Packaging process control |
| Action | Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 4/21/2026 via UPS. The notice explained the issue, potential risk. and requested that the affected product be returned by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return for credit or replacement product. Consignees were directed to share this notification with others in your organization as appropriate. If the product listed above has been forwarded to another facility, please notify the facility. For questions regardin |
| Quantity | 3210 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, S |
| FDA record | Open on fda.gov |