WEB Aneurysm Embolization System W4-6-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854111006112), received between Sep 19, 2019 and Sep 19, 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.

• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A MIDDLE CEREBRAL ARTERY ANEURYSM, THE MICROCATHETER RUPTURED THE DOME OF THE ANEURYSM. A WEB DEVICE WAS BEING ADVANCED THROUGH THE MICROCATHETER AT THE TIME. THE PATIENT WAS TREATED WITH BALLOON REMODELING AND SIX EMBOLIZATION COILS. AFTER EXTUBATION, THE PATIENT WAS REPORTED TO HAVE NO COGNITIVE IMPAIRMENT AND WAS MOVING BOTH SIDES OF THE BODY.

  Patient problems: Rupture

  MAUDE report 9091608 ↗

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.