BEUDAMED
    FDA Recall Terminated

    Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Manufactured by Thomas Medical Products, Malvern, PA. Product is intended for use to facilitate the intracardiac placement of interventional devices.

    Recall: Z-1071-2009 · Initiated December 24, 2008

    Recall

    Recall Number
    Z-1071-2009
    Event Number
    50771
    Firm
    Boston Scientific Corp
    FEI Number
    3001236349
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 24, 2008
    Posted
    April 9, 2009
    Terminated
    April 6, 2010
    Address
    150 Baytech Dr, San Jose, CA, 95134-2302

    Description

    Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Manufactured by Thomas Medical Products, Malvern, PA. Product is intended for use to facilitate the intracardiac placement of interventional devices.

    Reason

    The marker band may detach from the sheath and a clinical failure could result in an embolism.

    Action

    The firm initiated the recall on December 24, 2009 and notified consignees via "Urgent Company Initiated Medical Device Recall - Immediate Action Required" letters which explain the reason for the recall and request the affected product be returned to the Boston Scientific Corporation Distribution Center. An amendment letter with two additional Convoy Advanced Delivery Sheath Kit models (M0045748ST0 and M0045749ST0) was sent to affected customers on January 27, 2009. Direct questions about this recall to your local Sales Representative.

    Distribution

    Worldwide Distribution.

    Quantity

    31,340 of all units