← FDA ENFORCEMENT
Z-2739-2026Class II

Medtronic Perfusion Systems

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Medtronic Perfusion Systems
Product type
Device
Status
Ongoing
Report date
2026-07-22
Distribution
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Firm state
MN
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →