BEUDAMED
    FDA Enforcement Class II Terminated

    Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

    Recall: Z-0333-2017 · Reported November 9, 2016

    Enforcement

    Recall Number
    Z-0333-2017
    Event ID
    75447
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2016
    Initiation Date
    October 5, 2016
    Classification Date
    November 2, 2016
    Termination Date
    March 23, 2017
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515, United States

    Description

    Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

    Reason

    Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.

    Code Info

    Lots 18709130, 18709234, 18709643, 18774858, 18775292; Expiration 12/31/2019. Lots 18785727, 18785933, 18849986; Expiration 01/31/2019.

    Distribution

    Worldwide Distribution - US including AK, IL, OH and Internationally to: ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CZECH REPUBLIC ECUADOR EGYPT FRANCE GERMANY GREECE HUNGARY INDIA IRAN ISRAEL ITALIA JAPAN MEXICO NETHERLANDS NORWAY PERU PHILIPPINES POLAND RUSSIA SERBIA SINGAPORE SLOVAKIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND THAILAND TUNISIA TURKEY UK URUGUAY VIETNAM.

    Quantity

    1478 devices, all models and lot numbers.