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

Recall Z-2239-2023 — Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

U.S. FDA — Device Enforcement · United States · 2023-06-08 · 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-2239-2023
Date of alert
2023-06-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Argon Medical Devices, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
11481383
Reported risk: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
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.