BEUDAMED
    FDA Enforcement Class II Terminated

    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    Recall: Z-2471-2012 · Reported October 3, 2012

    Enforcement

    Recall Number
    Z-2471-2012
    Event ID
    63188
    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 3, 2012
    Initiation Date
    September 23, 2011
    Classification Date
    September 27, 2012
    Termination Date
    September 28, 2012
    Address
    9775 Toledo Way, N/A, Irvine, CA, 92618-1811, United States

    Description

    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    Reason

    The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

    Code Info

    Lot # 9374298

    Distribution

    Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.

    Quantity

    36 units