BEUDAMED
    FDA Recall Terminated

    These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

    Recall: Z-1051-2007 · Initiated March 23, 2007

    Recall

    Recall Number
    Z-1051-2007
    Event Number
    37769
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 23, 2007
    Posted
    July 11, 2007
    Terminated
    March 2, 2008
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

    Reason

    Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.

    Action

    An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.

    Distribution

    Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.

    Quantity

    539