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 breached, potentially allowing contamination. The affected products were distributed worldwide, including throughout the United States and multiple countries. These devices are used during heart surgery procedures that require cardiopulmonary bypass support.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; 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/b53134ff-4d59-49da-864c-bf3a924dbcb3