Xlumena brand NAVIX Access Device — Class II medical device recall Z-2167-2013
Terminated recall by Xlumena, Inc., reported 2013-09-18, distributed in AZ, CA, CO, FL, GA, IL, IN, NY…. A complaint investigation has found that product fractures can occur at the distal end of the catheter under l
| Recall number | Z-2167-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xlumena, Inc., Mountain View, CA, United States |
| Recall initiated | 2013-04-17 |
| Classified | 2013-09-09 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2013-09-23 |
| Distributed | AZ, CA, CO, FL, GA, IL, IN, NY, PA, SC, WA |
| Countries outside the US | CH, DE, DK, ES, NL |
| Quantity | 148 units |
| Reason classes | device malfunction |
| Model numbers | FG-00666, NVX-10-03 |
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.
Reason for recall
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2167-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.