BEUDAMED
    FDA Recall Terminated

    AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-40 F00820-43 BEA25-110/I20-30 F00820-44 BEA25-90/I20-30 F00820-45 BEA25-70/I20-30 F00820-57 BEA22-80/I20-40 F00820-71 BEA22-90/I20-30 F00820-72 BEA22-70/I20-30 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

    Recall: Z-1049-2017 · Initiated January 4, 2017

    Recall

    Recall Number
    Z-1049-2017
    Event Number
    76256
    FEI Number
    3011063223
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 4, 2017
    Posted
    January 19, 2017
    Terminated
    April 28, 2017
    Address
    Endologix 35, Hammond Irvine, CA, 92618-1607

    Description

    AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-40 F00820-43 BEA25-110/I20-30 F00820-44 BEA25-90/I20-30 F00820-45 BEA25-70/I20-30 F00820-57 BEA22-80/I20-40 F00820-71 BEA22-90/I20-30 F00820-72 BEA22-70/I20-30 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

    Reason

    Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

    Action

    Endologix sent a Dear Physician letter on 12/30/16 to inform them information related to the AFX Endovascular AAA System (AFX System). The letter provides updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. Customers were informed of the voluntary recall of the small remaining quantity of original AFX with Strata graft material, and the larger diameter sizes of AFX2. Customers with any questions are instructed to contact their Endologix representative. Customers with questions were instructed to call their Endologix representative. On 1/17/17, Endologix issued a press release to inform consumers that firm is resuming shipments of all sizes of AFX2 Endovascular AAA systems and appointed Laura Nagel as Vice President, Global Quality. Consumers are informed that the large diameter sizes of AFX2 were placed on temporary hold on 12/27/16 to investigate a manufacture issue.

    Distribution

    Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand.

    Quantity

    832 units