BEUDAMED
    FDA Recall Open, Classified

    Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

    Recall: Z-1317-2024 · Initiated February 16, 2024

    Recall

    Recall Number
    Z-1317-2024
    Event Number
    94167
    Firm
    Medtronic Inc.
    FEI Number
    2183870
    Product Code
    QAN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 16, 2024
    Posted
    March 19, 2024
    Address
    4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

    Reason

    There is a potential for sterile package breach.

    Action

    Medtronic issued and URGENT: MEDICAL DEVICE RECALL notice to it consignees on 02/16/2024 via FedEx. The notice explained the issue and requested the consignee immediately remove, and quarantine all impacted devices pending a follow-up communication providing additional information pertaining to product retrieval for this issue within 2-3 weeks.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.

    Quantity

    65 units