FDA-Device2026-05-27Class IIPACKAGING DEFECT
Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
What this means
Certain lots of the Medtronic DLP Retrograde Cannula (Model 94915), a catheter used during heart bypass surgery, may have a breach in their sterile packaging. This could allow contamination before the device is used. No injuries have been reported.
- Check if you have lot number 0231859673 (GTIN 20643169454808)
- Do not use affected units; quarantine and return them to Medtronic
- Contact Medtronic or your hospital supply chain immediately if you have this lot
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
280 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2221-2026More Medtronic recalls
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