BEUDAMED
    FDA Recall Terminated

    Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/10/7. Catalog Number M00514200. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    Recall: Z-1870-2010 · Initiated May 17, 2010

    Recall

    Recall Number
    Z-1870-2010
    Event Number
    55784
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    ESW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 17, 2010
    Posted
    June 25, 2010
    Terminated
    October 20, 2011
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/10/7. Catalog Number M00514200. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    Reason

    Suture related device failures during deployment and repositioning of the stent

    Action

    Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.

    Distribution

    Worldwide Distribution - Only US distributed product is affected by recall