BEUDAMED
    FDA Recall Terminated

    Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL

    Recall: Z-0591-06 · Initiated December 14, 2005

    Recall

    Recall Number
    Z-0591-06
    Event Number
    34219
    Firm
    Endologix Inc
    FEI Number
    1000125107
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2005
    Posted
    March 22, 2006
    Terminated
    March 22, 2012
    Address
    13900 Alton Pkwy, Ste 122, Irvine, CA, 92618-1621

    Description

    Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL

    Reason

    The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.

    Action

    The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05. Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05.

    Distribution

    For units still in distribution: AZ, DE, KS, PA, & TN

    Quantity

    17 (13 already used and 4 currently in distribution)