Xlumena, Inc. Recall: Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03
Xlumena, Inc. Recall: Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Xlumena, Inc.; Product: Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and di
| 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. |
| Reason for recall | A complaint investigation has found that product fractures can occur at the distal end of the catheter under load. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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. |
| Recall initiated | 20130417 |
| Recall number | Z-2167-2013 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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