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Xlumena, Inc. recalls Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and
Recalled September 18, 2013 · FDA recall Z-2167-2013 · Xlumena
Hazard
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load. · FDA Class II
Units
148 units
Sold at
Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.
Description
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Product
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.
Manufacturer(s)
Xlumena, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →