Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 18, 2013
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 visib
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Xlumena, Inc. recalled Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-006… - a moderate-severity action.
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-006… was recalled by Xlumena, Inc. in September 18, 2013. Reason: A complaint investigation has found that product fractures can occur at the distal end of the catheter under …. Check the official notice for the remedy. Verify recall #Z-2167-2013 with the FDA Devices before acting.
The recall
Xlumena, Inc. issued this moderate-severity FDA Devices recall-A complaint investigation has found that product fractures can occur at the distal end of the catheter under ….
- Moderate
- severity level
- 148 units
- affected scope
- Class II
- classification
- September 18, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2167-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2167-2013) was formally reported on September 18, 2013, with the manufacturer initiating the action on April 17, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Xlumena, Inc. is listed as the recalling firm, operating out of Mountain View, CA. Federal records list the affected scope as 148 units.
The documented reason for this recall is: A complaint investigation has found that product fractures can occur at the distal end of the catheter under load. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
148 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2167-2013 |
| Date reported | September 18, 2013 |
| Date initiated | April 17, 2013 |
| Recalling firm | Xlumena, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 148 units |
| Distribution | Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2167-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Xlumena, Inc.. Units affected: 148 units.
Why was this product recalled? ▼
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2013. Severity: Moderate. Recall number: Z-2167-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2167-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 18, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.