BEUDAMED
    FDA Recall Terminated

    Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA

    Recall: Z-1542-06 · Initiated September 8, 2006

    Recall

    Recall Number
    Z-1542-06
    Event Number
    36344
    Firm
    Micrus Endovascular Corporation
    FEI Number
    3003079393
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 8, 2006
    Posted
    September 29, 2006
    Terminated
    June 29, 2007
    Address
    821 Fox Lane, San Jose, CA, 95131

    Description

    Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA

    Reason

    During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.

    Action

    On 9/8/06 the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

    Distribution

    Worldwide

    Quantity

    413 units