BEUDAMED
    FDA Recall 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 · Initiated April 17, 2013

    Recall

    Recall Number
    Z-2167-2013
    Event Number
    64965
    Firm
    Xlumena, Inc.
    FEI Number
    3008516478
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 17, 2013
    Posted
    September 9, 2013
    Terminated
    September 23, 2013
    Address
    453 Ravendale Dr, Ste H, Mountain View, CA, 94043-5221

    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.

    Action

    Xlumena sent an Urgent Medical Device Recall letter dated April 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected product. Customers with questions were instructed to contact [email protected]. For question regarding this recall call 650-961-9901.

    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