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 94965), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier that protects the device before use. This affects 260 units distributed worldwide, including in the United States.
- Check if your facility received this device with lot numbers 0231665658 or C231786900
- Do not use affected units; contact your Medtronic representative for instructions on return or replacement
- Review any patients who may have received this device and follow your facility's protocol for post-operative monitoring
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
260 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2222-2026More 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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