BEUDAMED
    FDA Recall Terminated

    Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200

    Recall: Z-2322-2010 · Initiated July 15, 2010

    Recall

    Recall Number
    Z-2322-2010
    Event Number
    56331
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    ESW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 15, 2010
    Posted
    August 31, 2010
    Terminated
    October 14, 2011
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200

    Reason

    Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.

    Action

    Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.

    Distribution

    Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

    Quantity

    8 units