BEUDAMED
    FDA Recall Terminated

    Polyflex Esophageal Stent 20/16mm x 90mm

    Recall: Z-0818-03 · Initiated April 16, 2003

    Recall

    Recall Number
    Z-0818-03
    Event Number
    26136
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    ESW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 16, 2003
    Posted
    May 14, 2003
    Terminated
    July 20, 2004
    Address
    1 Boston Scientific Place, Natick, MA, 01760

    Description

    Polyflex Esophageal Stent 20/16mm x 90mm

    Reason

    Radiopaque marker bands may not be visible under fluoroscopy

    Action

    Boston Scientific notified domestic accounts by letter on April 16, 2003. The account wasinstructed to check inventory and return product. A Reply Verification form was provided to document amount of product in inventory.

    Distribution

    Nationwide

    Quantity

    5