Xlumena NAVIX Access Device Recalled for Catheter Fracture Risk
Xlumena is recalling 148 units of the NAVIX Access Device because a complaint investigation found the catheter can fracture at the distal end under load.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (fracture) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Xlumena, Inc. is recalling 148 units of the NAVIX Access Device, Model NVX-10-03, Part Number FG-00666. The device is a multi-lumen balloon catheter indicated for use as an accessory to cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst during endoscopic procedures.
The recall was initiated after a complaint investigation determined that product fractures can occur at the distal end of the catheter under load. The affected lots include FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, and FGS00091.
The product was distributed worldwide, including in the United States (AZ, CA, FL, GA, IN, NY, SC, WA, PA, IL, CO) and internationally to the Netherlands, Germany, Spain, Denmark, and Switzerland. Healthcare facilities and users should stop using the device and contact Xlumena, Inc. for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Xlumena, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 148
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- All lots are involved are being recalled
- including FGS00048
- FGS0005
- FGS00058
- FGS00059
- FGS00069
- FGS00073
- FGS00081
- FGS00086
- FGS00091
Distribution
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