BEUDAMED
    FDA Recall Terminated

    AFX Endovascular AAA System, Endoleak Type IIIA

    Recall: Z-1035-2017 · Initiated December 27, 2016

    Recall

    Recall Number
    Z-1035-2017
    Event Number
    76075
    FEI Number
    3011063223
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 27, 2016
    Posted
    January 18, 2017
    Terminated
    April 28, 2017
    Address
    Endologix 35, Hammond Irvine, CA, 92618-1607

    Description

    AFX Endovascular AAA System, Endoleak Type IIIA

    Reason

    Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).

    Action

    Endologix sent an Dear Physician letter dated June 2, 2015, were sent to customers to inform them that Endologix has enclosed the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). The customer letter includes update on the clinical programs and commercial experience (ie. post-market surveillance). On January 2016, Dear Physician letters were sent to customers to inform them that Endologix has enclosed the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and commercial experience (ie. post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of the devices. The customer letter includes updates on the Clinical Programs and Commercial experience. A Dear Physician letter, "Important Safety Update AFX Endovascular AAA System: Type III Endoleaks", was sent to provide important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers that Endologix has an active post-market surveillance program that has been monitoring and evaluating the performance of the AFX System since its introduction to the market in 2011. In January of 2013, Endologix conducted an investigation into reports of Type IIIa endoleaks (separation of bifurcated and extension stent grafts at the point of overlap), which was followed by an investigation into Type IIIb endoleaks (disruption of the stent graft material) in September of 2013. For further questions please call (949) 595-7200.

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    40,967