Recall Z-2167-2013— Xlumena, Inc.

Name: FDA recall Z-2167-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-17

Class II · Terminated

Class II FDA medical device recall by Xlumena, Inc., initiated 2013-04-17, terminated 2013-09-23. It names one FDA 510(k) clearance: K093279. 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.. Reason: A complaint investigation has found that product fractures can occur at the distal end of the catheter under load..

Recalling firm: Xlumena, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-17
Terminated: 2013-09-23
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K093279 — NAVIX ACCESS DEVICEXlumena·cleared 2010-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.