Z-2167-2013Class II

Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is...

Name: Z-2167-2013 Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is...
Creator: Xlumena, Inc.
Published: 2013-04-17
License: https://open.fda.gov/license/

Xlumena, Inc. / initiated 2013-04-17 / Terminated / root cause: manufacturing process

FDA source

Xlumena, Inc. began a recall of Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain... on 2013-04-17. FDA classified it as Class II and gives the reason as "A complaint investigation has found that product fractures can occur at the distal end of the catheter under load". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2167-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-17
Posted: 2013-09-09
Terminated: 2013-09-23
Recalling firm: Xlumena, Inc.
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Xlumena sent an Urgent Medical Device Recall letter dated April 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected product. Customers with questions were instructed to contact [email protected]. For question regarding this recall call 650-961-9901.
Quantity in commerce: 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.
Product codes and lots: All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2167-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2167-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-09

Product code GCJ

K093279Class IINavix Access DeviceXlumena / cleared 2010-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)