Z-2167-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2013
- Initiation Date
- April 17, 2013
- Termination Date
- September 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148 units
Product 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 for Recall
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
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.
Code Information
All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091