Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-2738-2026 · Posted 2026-07-15

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2026-05-25

Reason for Recall

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

Firm 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.

Root Cause

Packaging

Distribution Pattern

Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180456Bio-Medicus Adult Cannulae KitMedtronic, Inc. · 2018-03-22K024069ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106Medtronic Vascular · 2003-01-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑