BEUDAMED
    FDA Recall Terminated

    MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.

    Recall: Z-3103-2017 · Initiated August 7, 2017

    Recall

    Recall Number
    Z-3103-2017
    Event Number
    77880
    Firm
    Microvention, Inc.
    FEI Number
    3003523199
    Product Code
    MOF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 7, 2017
    Terminated
    October 26, 2018
    Address
    1311 Valencia Ave, Tustin, CA, 92780-6447

    Description

    MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.

    Reason

    There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

    Action

    Letters dated 8/7/2017 were issued on 8/7/2017 via overnight mail to the direct account medical facilities.

    Distribution

    Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution.

    Quantity

    34 units