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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic BioMedicus

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 Class 2 Device Recall Medtronic BioMedicussee related information
Date Initiated by FirmMay 25, 2026
Date PostedJuly 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2739-2026
Recall Event ID 99199
510(K)NumberK153598 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductMedtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Code Information MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
FEI Number 1000116158
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information ContactMedtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
FDA Determined
Cause 2		Packaging
ActionMedtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 6/4/2026 via courier. The notice explained the problem, potential risk, and requested the product be discarded in a clearly marked biohazard bag or container and discarded. Consignees were directed to complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com and contact Medtronic Customer Service at 1-800-854-3570, Option 1 then Option 4, and reference this communication to initiate to arrange for credit or replacement product. Consignees were requested to share within their organization and If the product was forwarded to another facility, to notify those to whom the affected product was transferred.
DistributionWorldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DWF
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