BEUDAMED
    FDA Recall Terminated

    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.

    Recall: Z-0593-2010 · Initiated November 25, 2009

    Recall

    Recall Number
    Z-0593-2010
    Event Number
    53983
    Firm
    Endologix Inc
    FEI Number
    1000125107
    Product Code
    OAD
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 25, 2009
    Posted
    January 11, 2010
    Terminated
    May 7, 2010
    Address
    11 Studebaker, Irvine, CA, 92618-2013

    Description

    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.

    Reason

    This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health c

    Action

    The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.

    Distribution

    Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.

    Quantity

    3 UNITS DISTRIBUTED: 1 LOT W09-2966, 2 LOT W09-2998