BEUDAMED
    FDA Recall 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 · Initiated March 16, 2021

    Recall

    Recall Number
    Z-1532-2021
    Event Number
    87638
    Firm
    Medtronic Inc.
    FEI Number
    2183870
    Product Code
    QAN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 16, 2021
    Terminated
    April 15, 2024
    Address
    4600 Nathan Ln N, Plymouth, MN, 55442-2890

    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.

    Action

    Beginning 16-Mar-2021, Medtronic initiated verbal communications to consignees in possession of affected units. Consignees were advised to quarantine all affected units within their possession, pending retrieval. A written Medical Device Correction letter was mailed on 03/30/2021 via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. Consignees are also asked to return all unused, affected product within their possession.

    Distribution

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

    Quantity

    23 devices