CLASS II Device recall · Reported 18 Sep 2013 · FDA Enforcement Report

Navix Access Device recalled by Xlumena

Xlumena is recalling Xlumena Navix Access Device, distributed nationwide in the US. The recall was initiated on 17 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091

Quantity recalled148 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2167-2013
FDA event ID: 64965
Recalling firm: Xlumena, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Apr 2013
FDA classified: 9 Sep 2013
Reported: 18 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

17 Apr 2013	Recall initiated by company
9 Sep 2013	Classified by FDA	+145 days
18 Sep 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.

Nationwide Arizona California Colorado Florida Georgia Illinois Indiana New York Pennsylvania South Carolina Washington

Questions about this recall

Is Navix Access Device recalled?

Yes. Xlumena recalled Navix Access Device on 17 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-2167-2013.

Why was it recalled?

A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

Which lots are affected?

All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091

Where was it sold?

Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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