Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recall Summary Medtronic is recalling certain lots of DLP Retrograde Cannula and cardiopulmonary bypass vascular catheters because the sterile barrier may be compromised, potentially allowing contamination. These devices are used during heart surgery procedures and have been distributed across the United States and 38 other countries worldwide. The recall affects specific product lots rather than all units manufactured.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
- Reason
- Certain lots of product have the potential for a sterile barrier breach.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3d90b8ce-8e16-4afe-91cb-7244fd44c3fb