BEUDAMED
    FDA Enforcement Class II Terminated

    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    Recall: Z-1037-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1037-2017
    Event ID
    76086
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Endologix
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    December 27, 2016
    Classification Date
    January 18, 2017
    Termination Date
    April 28, 2017
    Address
    35 Hammond, Irvine, CA, 92618-1607, United States

    Description

    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    Reason

    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

    Code Info

    The correction is not lot specific. It applies to AFX procedures conducted after July 2015

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.