FDA-Device2026-05-27Class IIPACKAGING DEFECT
Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
OTHERNationwide distribution
Medtronic DLP Retrograde Cannula recalled for sterile barrier breach
Certain lots of Medtronic DLP Retrograde Cannula (Model 94665) used in heart-lung bypass surgery may have a compromised sterile barrier. This could allow contamination of the device before use. The affected lots have been identified and distributed worldwide.
- Check if your facility has the affected lot numbers: 0231823435, 0231961203 (GTIN 00643169454705) or 0231823435, 0231823478, 0231961203 (GTIN 20643169454709).
- Do not use affected lots; contact Medtronic for instructions on return or replacement.
- Review your inventory and notify your surgical team immediately if you have affected stock.
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
840 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2217-2026More 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 GUNDRY 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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