Reported Sep 18, 2013 · Terminated
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured…
Xlumena, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Xlumena, Inc. · 453 Ravendale Dr Ste H · Mountain View, CA · 94043-5221
Is this the product you have?
- Xlumena brand NAVIX Access Device
- Model/Catalogue NumberNVX-10-03
- Part NumberFG-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
- Lot codes and dates
All lots are involved are being recalledincluding FGS00048FGS0005FGS00058FGS00059FGS00069FGS00073FGS00081FGS00086FGS00091
- Amount recalled
- 148 units
Where it was sold
Why it was recalled
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
This product could cause temporary or reversible health problems — stop using it.
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