Medtronic Perfusion Systems recalls Medtronic DLP One-Piece Pediatric Arterial Cannula

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

Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula

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.

• FDA enforcement recordOfficial FDA database entry for Z-2738-2026
• FDA 510(k) clearance · K024069The device's official FDA premarket clearance record
• FDA 510(k) clearance · K180456The 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.