BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0464-2022 · Initiated November 19, 2021

    Recall

    Recall Number
    Z-0464-2022
    Event Number
    89140
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    QAN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 19, 2021
    Terminated
    August 16, 2024
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    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.

    Action

    The firm issued letters dated November 2021 on 11/19/2021 via 2-day UPS delivery to the U.S. consignees. The letter informs the consignee of the upcoming updates to the Instruction for Use (IFU) for the Abre venous self-expanding stent system and explains the updates will provide new information to help mitigate the risk of possible stent migration. The Customer Instructions in the letter requests the enclosed upcoming updates to the IFU be reviewed, the letter is shared with all those who need to be aware within their organization, patients should continue to be monitored per their practice's normal follow-up procedures, and the enclosed Customer Confirmation Form be completed and emailed to the firm. The updated electronic IFU will be available before the end of the calendar year. In Outside the United States (OUS) geographies, communication of the Medical Device Correction letter began 11/24/2021 via regionally approved methods. Consignees will be notified of the upcoming IFU change, as well as provided the content of the IFU change. Consignees will be asked to complete and return a confirmation certificate confirming they have received the notification. The IFU for OUS consignees will be available in the summer of 2022.

    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