Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xlumena brand NAVIX Access Device Recalled by Xlumena, Inc. Due to A complaint investigation has found that product fractures...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Xlumena, Inc. directly.
Affected Products
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.
Quantity: 148 units
Why Was This Recalled?
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Where Was This Sold?
This product was distributed to 11 states: AZ, CA, CO, FL, GA, IL, IN, NY, PA, SC, WA
About Xlumena, Inc.
Xlumena, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report