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 94725), a catheter used in heart surgery, may have a breach in their sterile packaging. This could potentially expose the device to contamination before use. The affected lots have been identified by lot number and GTIN code.
- Check if your facility has received any of the affected lot numbers listed in this recall.
- Do not use affected units; quarantine them and contact Medtronic immediately.
- Review the full lot number list and GTINs provided by Medtronic to confirm whether your inventory is affected.
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
2620 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2218-2026More 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 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
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
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