BEUDAMED
    FDA Recall Terminated

    The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.

    Recall: Z-0410-06 · Initiated December 7, 2005

    Recall

    Recall Number
    Z-0410-06
    Event Number
    34504
    Firm
    Boston Scientific Corporation
    FEI Number
    2024805
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 7, 2005
    Posted
    February 1, 2006
    Terminated
    August 10, 2007
    Address
    3574 Ruffin Rd, San Diego, CA, 92123-2597

    Description

    The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.

    Reason

    The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

    Action

    All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.

    Distribution

    Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain Sweden Switzerland & Turkey

    Quantity

    individual qty in US:376, Worldwide distribution pending.