Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2167-2013 — 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 d

U.S. FDA — Device Enforcement · United States · 2013-04-17 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2167-2013
Date of alert: 2013-04-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Xlumena, Inc.
Product category: device
Product type: Devices

Reported risk: A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related