BEUDAMED
    FDA Recall Terminated

    Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL

    Recall: Z-0310-2007 · Initiated November 8, 2006

    Recall

    Recall Number
    Z-0310-2007
    Event Number
    36803
    Firm
    Endologix Inc
    FEI Number
    1000125107
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 8, 2006
    Posted
    December 27, 2006
    Terminated
    November 4, 2011
    Address
    11 Studebaker, Irvine, CA, 92618-2013

    Description

    Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL

    Reason

    Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.

    Action

    The affected hospitals were contacted telephone on 11/08/06 and in writing (Recall Letters) sent via FedEx 11/09/06. The firm also released a press statement on 11/10/06. All affected consignees have been contacted and instructed to return the specified products to Endologix.

    Distribution

    Worldwide, including USA and Germany.

    Quantity

    19