BEUDAMED
    FDA Enforcement Class II Ongoing

    Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

    Recall: Z-1643-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1643-2025
    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 Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

    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

    Models: 1. 9-TVLP4F90/060; UDI-DI 00811806011561 Lots 9114256 9125090 9157327 9211450 10005333 10080103 10092488 10092519 10212158 10248201 10265245 10333989 10334851 10353324 2. 9-TVLP4F90/080; UDI-DI 00811806011578 Lots 9206150 10040010 10068340 10227816 10341801

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    4,850