BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1644-2025 · Initiated March 17, 2025

    Recall

    Recall Number
    Z-1644-2025
    Event Number
    96545
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    DQY
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 17, 2025
    Posted
    April 21, 2025
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    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.

    Action

    On March 17, 2025, the firm notified customers via hand-delivered customer communications titled "Urgent Medical Device Recall." Customers were instructed to share the notice with applicable personnel and to return any remaining unused devices from impacted lots. Abbott representatives will assist with product return and replenishment. If you have any questions, please contact your local Sales Representative or Abbott Support at 1-800-544-1664.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    2683