Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Adult Cannula Kit
Reason for recall
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Lot / code information
MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
What the firm is doing
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 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.
DistributionShow detailsHide
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2739-2026
- FDA 510(k) clearance · K153598The device's official FDA premarket clearance record
- FDA device classification · DWFOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.4210The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medtronic Perfusion SystemsSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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