Device 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.
Z-2167-2013
Product summary
- Firm
- Xlumena, Inc.
- Event
- Event 64965
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148 units
- Official record key
device-enforcement:Z-2167-2013
Official wording
Reason: A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Code information: All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091
Distribution pattern: Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.
Derived failure modes
-
Unknown
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.