BEUDAMED
    FDA Enforcement Class II Terminated

    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

    Recall: Z-0464-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0464-2022
    Event ID
    89140
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    November 19, 2021
    Classification Date
    January 6, 2022
    Termination Date
    August 16, 2024
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    Description

    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

    Reason

    There have been reports of stent migration.

    Code Info

    The IFU for all model numbers and serial numbers.

    Distribution

    Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,

    Quantity

    21,653 devices