BEUDAMED
    FDA Enforcement Class II Terminated

    Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    Recall: Z-2178-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2178-2016
    Event ID
    74425
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2016
    Initiation Date
    June 6, 2016
    Classification Date
    July 11, 2016
    Termination Date
    March 3, 2017
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515, United States

    Description

    Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    Reason

    Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.

    Code Info

    MODEL Number:M0035452020: Lot Number/Expiration Date: 19056683 31-May-19 19060338 31-May-19 18985514 30-Apr-19 19034323 31-May-19 18970562 30-Apr-19.

    Distribution

    Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.

    Quantity

    45,302 (8,188 in the U.S.) - total, all model numbers