FDA-Device2026-05-27Class IIPACKAGING DEFECT
Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
What this means
Certain lots of Medtronic DLP Retrograde Cannula (Model 94215T), a catheter used during heart surgery, may have a compromised sterile barrier. This affects 600 units distributed worldwide. No injuries have been reported.
- Check if your facility received affected lots: 0231881762, 0231881786, 0231931962, 0231962106, or C233032040
- Do not use affected product; contact Medtronic for instructions on replacement or return
- Notify your procurement or clinical engineering team immediately
The agency's original wording
Hazard
Certain lots of product have the potential for a sterile barrier breach.
Intended for
Adults
Illnesses reported
None reported
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
600 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2216-2026More Medtronic recalls
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