Z-2739-2026Class II

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

Name: Z-2739-2026 Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Creator: Medtronic Perfusion Systems
Published: 2026-05-25
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2026-05-25 / Open, Classified / root cause: packaging

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula on 2026-05-25. FDA classified it as Class II and gives the reason as "Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2739-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-25
Posted: 2026-07-15
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medtronic 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 [email protected] 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.
Distribution: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Product codes and lots: MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2739-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2738-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15
Z-2739-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15

Product code DWF

K153598Class IIMedtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. / cleared 2016-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)