Medtronic Perfusion Systems Recall
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Updated April 21, 2026
Medtronic Perfusion Systems is recalling Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter. Hazard: Certain lots of product have the potential for a sterile barrier breach.
Is the Medtronic Perfusion Systems recalled? Yes. This product was recalled by FDA on April 21, 2026. Details below.
What is recalled
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Am I affected
You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.
What to do right now
Voluntary: Firm initiated
The hazard
Certain lots of product have the potential for a sterile barrier breach.
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-Z-2214-2026
- Classification
- Class II
- Recalled
- April 21, 2026
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