BEUDAMED
    FDA Enforcement Class I Terminated

    HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    Recall: Z-1822-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1822-2014
    Event ID
    68419
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nitinol Devices and Components, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    May 28, 2014
    Classification Date
    June 25, 2014
    Termination Date
    January 13, 2015
    Address
    47533 Westinghouse Dr, N/A, Fremont, CA, 94539-7463, United States

    Description

    HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    Reason

    Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

    Code Info

    Model HPSS35180- all lots.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

    Quantity

    8485 in US, 9595 - ROW - total, all models