Recall
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

View original FDA notice →

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