BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    Recall: Z-0858-2011 · Initiated October 19, 2010

    Recall

    Recall Number
    Z-0858-2011
    Event Number
    57179
    Firm
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515
    FEI Number
    2939204
    Product Code
    HGC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 19, 2010
    Posted
    January 5, 2011
    Terminated
    January 27, 2012

    Description

    Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    Reason

    The product appears to have premature degradation of the PGLA coating on the Matrix Coil.

    Action

    US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.

    Distribution

    Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.

    Quantity

    77,364 total units