BEUDAMED
    FDA Enforcement Class II Terminated

    -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.

    Recall: Z-0120-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0120-2016
    Event ID
    72165
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 21, 2015
    Initiation Date
    September 4, 2015
    Classification Date
    October 14, 2015
    Termination Date
    May 18, 2017
    Address
    9775 Toledo Way, N/A, Irvine, CA, 92618-1811, United States

    Description

    -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.

    Reason

    The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.

    Code Info

    Pipeline Model Number Lot Number FA-77250-16V06 9724629 FA-77350-16V10 A024276 FA-77350-16V12 A012865 FA-77350-18Vl0 A013596 FA-77350-20V12 A012039 FA-77375-14V12 A013029 FA-77375-16Vl2 A011629 FA-77375-16Vl2 A029223 FA-77375-16Vl2 A031361 FA-77375-18V10 A024213 FA-77375-20Vl2 A029315 FA-77400-14V12 A012885 FA-77425-18V12 A026942 FA-77450-14V12 A013028 FA-77475-20Vl2 A012383 FA-77500-16Vl2 A029316 Pipeline Flex Model Number Lot Number PED-400-20VO1 9977371 PED-475-20V01 A047151 PED-375-18V01 9971250

    Distribution

    US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees.

    Quantity

    23 devices