BEUDAMED
    FDA Recall 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 · Initiated August 10, 2018

    Recall

    Recall Number
    Z-3022-2018
    Event Number
    80831
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    FEI Number
    3004904811
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 10, 2018
    Terminated
    August 4, 2020
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    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.

    Action

    Medtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product.

    Distribution

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

    Quantity

    67 units