FDA-Device2026-07-22Class IIPROCESSING DEFECT
Medtronic Bio-Medicus Adult Cannula Kit recalled for loose foreign material with blood
What this means
Medtronic received two complaints of loose foreign material inside the Bio-Medicus Adult Cannula Kit used during heart-lung bypass surgery. Testing confirmed the material contained trace levels of blood. No injuries have been reported.
- If you operate or work with this product (Lot 230257001), contact your Medtronic representative or local hospital supply chain team for guidance.
- Do not use affected units until you confirm the lot number and receive instructions.
The agency's original wording
Hazard
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2739-2026Want us to check the next one for you?
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