BEUDAMED
    FDA Enforcement Class II Ongoing

    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

    Recall: Z-1644-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1644-2025
    Event ID
    96545
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2025
    Initiation Date
    March 17, 2025
    Classification Date
    April 21, 2025
    Address
    5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States

    Description

    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

    Reason

    Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

    Code Info

    UDI-DI 00811806012926 Lots 9078966 9093895 9134623 9144113 9148110 9148579 9155868 9158302 9241591 9241593 10004059 10011461 10011462 10011463 10011465 10017790 10017792 10196106 10196119 10198795 10198801 10198889 10207472 10207503 10274454 10283818

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    2683