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.
FDA Recall Z-2167-2013 · Posted 2013-09-09
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Recalling FirmXlumena, Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2013-04-17
Date Terminated2013-09-23
Product Quantity148 units
Reason for Recall
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Firm 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.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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