BEUDAMED
    FDA Recall Terminated

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110.

    Recall: Z-1679-2009 · Initiated March 23, 2009

    Recall

    Recall Number
    Z-1679-2009
    Event Number
    51713
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 23, 2009
    Posted
    July 14, 2009
    Terminated
    October 18, 2012
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110.

    Reason

    Lead connection issues or fracture increases probability of inappropriate therapy: Inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.

    Action

    Boston Scientific sent an Urgent Medical Device Information letter, dated March 23, 2009, to physicians following implanted devices. The letter described the issue, the rate of occurance and provided Patient Management Recommendations.

    Distribution

    Worldwide distribution: USA, Guam, Puerto Rico, Aruba, Austria, Belgium, Brazil, Canada, Cayman Islands, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Netherlands, New Caledonia, Norway, Philippines, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.

    Quantity

    49,148 total