BEUDAMED
    FDA Recall Terminated

    Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA

    Recall: Z-1161-2007 · Initiated May 1, 2007

    Recall

    Recall Number
    Z-1161-2007
    Event Number
    38117
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    NIM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 1, 2007
    Posted
    August 9, 2007
    Terminated
    March 2, 2008
    Address
    Scientific Place Natick, MA, 01760

    Description

    Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA

    Reason

    Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.

    Action

    On May 1, 2007, Boston Scientific initiated a Customer Notification worldwide. On May 21, 2007 Boston Scientific expanded this field action to a recall/removal status for Germany. Affected customers were notified in Germany on May 24, 2007.

    Distribution

    Worldwide, including USA, France, Italy, Germany, Belgium, Cyprus, Austria, Spain, Finland, Netherlands, Luxembourg, Romania , Czech Republic, Poland, Israel, Hungary, New Zealand, and Switzerland.

    Quantity

    2487