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Medtronic Perfusion Systems: Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula

Medical DevicesSource: FDA (device) · Date: 2026-07-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic Perfusion Systems
Product
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Reason / hazard
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Recall initiated
2026-05-25
Code info
MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
Voluntary mandated
Voluntary: Firm initiated
City
Brooklyn Park
State
MN
Country
United States
Event id
99199
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