BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    Recall: Z-1532-2021 · Reported May 12, 2021

    Enforcement

    Recall Number
    Z-1532-2021
    Event ID
    87638
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 12, 2021
    Initiation Date
    March 16, 2021
    Classification Date
    May 5, 2021
    Termination Date
    April 15, 2024
    Address
    4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States

    Description

    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    Reason

    Incorrect size printed on the device; packaging is labeled correctly.

    Code Info

    UDI 00643169796348, Lot Number B086915

    Distribution

    US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.

    Quantity

    23 devices