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

Recall Z-0170-2023 — WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.

U.S. FDA — Device Enforcement · United States · 2022-09-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0170-2023
Date of alert
2022-09-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MICROVENTION INC.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00842429103128
Reported risk: Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.