BEUDAMED
    FDA Enforcement Class II Terminated

    ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.

    Recall: Z-3022-2018 · Reported September 19, 2018

    Enforcement

    Recall Number
    Z-3022-2018
    Event ID
    80831
    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
    September 19, 2018
    Initiation Date
    August 10, 2018
    Classification Date
    September 11, 2018
    Termination Date
    August 4, 2020
    Address
    9775 Toledo Way, N/A, Irvine, CA, 92618-1811, United States

    Description

    ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.

    Reason

    The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.

    Code Info

    Lot Number A495368

    Distribution

    Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China

    Quantity

    67 units