BEUDAMED
    FDA Enforcement Class I Terminated

    Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

    Recall: Z-1453-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1453-2014
    Event ID
    67893
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    April 1, 2014
    Classification Date
    April 16, 2014
    Termination Date
    October 31, 2014
    Address
    9775 Toledo Way, N/A, Irvine, CA, 92618-1811, United States

    Description

    Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

    Reason

    Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

    Code Info

    PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856431 FA7730010 / 9869991 FA7737514 / 9855933 FA7742518 / 9860762 FA7732514 / 9873854 FA7737516 / 9858010 FA7745014 / 9874111 FA7735014 / 9855265 FA7740016 / 9859214 FA7745016 / 9879736 FA7735014 / 9875267 FA7740016 / 9879180 FA7747514 / 9868888

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.

    Quantity

    32 units total (23 units in US)