FDAHealthMay 25, 2026
Medtronic Perfusion Systems — Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
⚠️ Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 25, 2026
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
What's affected?
- Product
- Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
- Lot code
- 230257001
Additional details
MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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