BEUDAMED
    FDA Recall Terminated

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    Recall: Z-0965-2013 · Initiated March 1, 2013

    Recall

    Recall Number
    Z-0965-2013
    Event Number
    64546
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 1, 2013
    Posted
    March 18, 2013
    Terminated
    May 23, 2013
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    Reason

    An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.

    Action

    Consignees were sent a Boston Scientific "Important Medical Device Information" letter dated March 1, 2012. The letter was addressed to "Dear Doctor". The letter described the product involved in the recall, the problem and provided Recommendations/Actions. US customers may contact Technical Services for more information at 800-227-3422.

    Distribution

    Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.

    Quantity

    2090 (570 USA; 1520 OUS)