Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIOngoing
Summary: Medtronic Perfusion Systems is recalling Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter. Reason: Certain lots of product have the potential for a sterile barrier breach.
What is being recalled
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Why
Certain lots of product have the potential for a sterile barrier breach.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
How to tell if yours is affected
GTIN 00673978188447, Lot Numbers: 0231651336; GTIN 20643169454877, Lot Numbers: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2214-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 21, 2026 |
| Reported | May 27, 2026 |
| Company | Medtronic Perfusion Systems |
| Company location | Brooklyn Park, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3790 units |
More recalls from Medtronic Perfusion Systems · all medical device recalls · recalls from April 2026