WEB Aneurysm Embolization System W4-6-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854111006105), received between Nov 14, 2019 and Nov 14, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (P170032); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A WEB DEVICE WAS BEING PARTIALLY DEPLOYED WHEN IT WAS NOTICED THAT THE TIP OF THE WEB WAS IN THE SUBARACHNOID SPACE. ANGIOGRAPHY WITH CONTRAST INJECTION CONFIRMED EXTRAVASATION INTO THE SUBARACHNOID SPACE. PROTAMINE WAS ADMINISTERED. AN LVIS STENT, THE WEB DEVICE, AND EMBOLIZATION COILS WERE USED TO EMBOLIZE THE ANEURYSM. THE PATIENT WAS SENT FOR AN EMERGENT HEAD CTA FOLLOWING THE PROCEDURE. THE PATIENT WOKE UP NEUROLOGICALLY INTACT AFTER THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY REPORTED SEQUELAE.

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 9325425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170032. One submission often covers many models, so check the product and lot details in each record.

• Z-0170-2023 · Sep 21, 2022 · Open, Classified
  WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.