Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recall Summary Medtronic is recalling certain lots of DLP Retrograde Cannula and cardiopulmonary bypass catheters because the sterile barrier—the protective covering that keeps these devices free from contamination—may be breached in some units. These devices are used during heart surgery and bypass procedures and have been distributed nationwide in the US and in numerous countries worldwide. This is classified as a Class II recall, indicating a potential health risk.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; 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/27e698aa-bd31-4dbb-a8c0-733b8d5f4474