BEUDAMED
    FDA Enforcement Class II Terminated

    Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.

    Recall: Z-2167-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2167-2013
    Event ID
    64965
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xlumena, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    April 17, 2013
    Classification Date
    September 9, 2013
    Termination Date
    September 23, 2013
    Address
    453 Ravendale Dr Ste H, N/A, Mountain View, CA, 94043-5221, United States

    Description

    Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.

    Reason

    A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

    Code Info

    All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091

    Distribution

    Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.

    Quantity

    148 units