BEUDAMED
    FDA Enforcement Class II Terminated

    Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    Recall: Z-2181-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2181-2016
    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 6CM MODEL Number:M0035452060 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:M0035452060; Lot Number/Expiration Date: 18777380 31-Dec-18 18538894 31-Aug-18 18726354 30-Nov-18 18830541 31-Jan-19 18802659 31-Jan-19 18776332 31-Dec-18 18499021 31-Jul-18 18743910 30-Nov-18 18725944 30-Nov-18 18454649 30-Jun-18 18794568 31-Jan-19 18538832 31-Aug-18 18829512 31-Jan-19 18801344 31-Jan-19 18709049 30-Nov-18 18693095 30-Nov-18 18499207 31-Jul-18 19032899 30-Apr-19 19047487 31-May-19 18852469 28-Feb-19 18954631 31-Mar-19 18906669 28-Feb-19 18877336 28-Feb-19 19037939 31-May-19 18973118 30-Apr-19 18899998 28-Feb-19 18900840 28-Feb-19 19046456 31-May-19 18972772 30-Apr-19 18955537 31-Mar-19 19005724 30-Apr-19 18935230 31-Mar-19 18925282 31-Mar-19 18876468 28-Feb-19 19032992 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