BEUDAMED
    FDA Recall Open, Classified

    Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

    Recall: Z-0289-2025 · Initiated October 3, 2024

    Recall

    Recall Number
    Z-0289-2025
    Event Number
    95507
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 3, 2024
    Posted
    November 4, 2024
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

    Reason

    There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

    Action

    Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 10/03/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested the affected product be quarantined pending return. The notice is to be shared with all individuals with each facility as appropriate, and the notice distributed to all facilities to which the affected devices was shipped. Contact the local Medtronic Field Representative for questions.

    Distribution

    US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore

    Quantity

    420 units