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U.S. Department of Health and Human Services

Class 2 Device Recall Xlumena brand NAVIX Access Device

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  Class 2 Device Recall Xlumena brand NAVIX Access Device see related information
Date Initiated by Firm April 17, 2013
Date Posted September 09, 2013
Recall Status1 Terminated 3 on September 23, 2013
Recall Number Z-2167-2013
Recall Event ID 64965
510(K)Number K093279  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
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.
Code Information All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091
Recalling Firm/
Manufacturer		 Xlumena, Inc.
453 Ravendale Dr Ste H
Mountain View CA 94043-5221
Manufacturer Reason
for Recall		 A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
FDA Determined
Cause 2		 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 dhasker@xlumena.com. 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = XLUMENA
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