BEUDAMED
    FDA Recall Terminated

    Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.

    Recall: Z-0839-2007 · Initiated April 5, 2007

    Recall

    Recall Number
    Z-0839-2007
    Event Number
    37821
    FEI Number
    3004904811
    Product Code
    MKI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2007
    Posted
    June 7, 2007
    Terminated
    August 23, 2012
    Address
    EV3 Neurovascular 9775 Toledo Way, Irvine, CA, 92618-2054

    Description

    Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.

    Reason

    Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.

    Action

    A recall plan was developed for 100% recovery of guidewires within affected lot numbers. The plan includes notification to U.S., European, and Rest-of-World customers and distributors. A recall notification letter was prepared 04/05/2007 which summarizes the coating problem and potential risks, identifies the affected lot numbers and quantities shipped to the customer, and provides instructions for return of unused guidewires.

    Distribution

    Worldwide, including USA, Italy, United Kingdom, Switzerland, Germany, Belgium, South Africa, Canada, Slovenia, China, Austria, France, Spain, Jordan, Mexico, Portugal, Colombia, Greece, Brazil, Venezula, Ireland, Australia, Malaysia, Saudi Arabia, South Korea, Lithuania, Netherlands, Hungary, and United Arab Emirates

    Quantity

    2120