WEB Aneurysm Embolization System W4-7-3-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429107089), received between Nov 11, 2020 and Nov 11, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE WEB, BLOOD APPEARED TO BE COMING FROM THE ANEURYSM INTO THE SUBARACHNOID SPACE. THE WEB WAS DETACHED IN THE ANEURYSM AND THE BLEEDING STOPPED. POST-PROCEDURE, THE PATIENT WAS REPORTED TO BE "FINE" AND IS CURRENTLY DOING WELL. THERE WAS NO SEQUELA. THERE WAS NO REPORTED DEVICE MALFUNCTION.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10826791 ↗

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.