FDA-Device2026-05-27Class IIPACKAGING DEFECT
Medtronic DLP Retrograde Cannula recalled for potential sterile barrier breach
What this means
Certain lots of Medtronic DLP Retrograde Cannula (Model 94913), a catheter used in heart-lung bypass surgery, may have a compromised sterile barrier. This could allow contamination before use. The affected product was distributed worldwide, including the United States.
- Check if your facility has inventory of the affected lot numbers listed in this recall
- Do not use affected units; quarantine them immediately
- Contact Medtronic or your supplier for instructions on return or replacement
- Notify your hospital's quality and surgical teams of the recall
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
3210 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2219-2026More Medtronic recalls
- FDA-Device2026-07-22Medtronic DLP One-Piece Pediatric Arterial Cannula recalled for loose foreign material with blood
- FDA-Device2026-07-22Medtronic Bio-Medicus Adult Cannula Kit recalled for loose foreign material with blood
- FDA-Device2026-07-01Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
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