FDA-Device2026-05-27Class IIPACKAGING DEFECT
Medtronic GUNDRY Retrograde Cannula recalled for sterile barrier breach risk
OTHERNationwide distribution
Medtronic GUNDRY Retrograde Cannula recalled for sterile barrier breach
Certain lots of Medtronic GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier. This could allow contamination of the sterile product before use during heart surgery.
- Check if your facility received affected lot numbers (see full recall notice for complete list)
- Do not use products from affected lots
- Contact Medtronic or your supplier for instructions on returns or replacements
- Review your inventory against the lot numbers in the original FDA notice
Hazard
Certain lots of product have the potential for a sterile barrier breach.
Sold states
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.
Affected count
3790 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2214-2026More Medtronic Perfusion Systems recalls
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for potential sterile barrier breach
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
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