Home/Recalls/FDA-Z-2739-2026
FDA DevicesClass II

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

Published: July 22, 2026Recall ID: Z-2739-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

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

Recalling Firm: Medtronic Perfusion Systems

Reason for Recall / Hazard

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Product Description & Identification

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

Additional Source Details

FieldValue
CityBrooklyn Park
StateMN
Event id99199
Address 17611 Northland Dr N
Code infoMATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
Postal code55428-1088
Report date20260722
Product typeDevices
Reason for recallMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260525
Initial firm notificationLetter
Center classification date20260715

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Overview

  • Recalling FirmMedtronic Perfusion Systems
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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