Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recall Summary Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94115T) and related cardiopulmonary bypass vascular catheters worldwide because the sterile barrier may be compromised in some units. This is a Class II recall, meaning the product could cause serious health problems or failure. The affected products were distributed across all U.S. states and multiple countries including Canada, Australia, Japan, and many European nations.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; 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/f7edb93d-254f-43b5-9841-d6375c8a907c