WEB Aneurysm Embolization System W2-8-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00856956005831), received between Apr 3, 2024 and Apr 3, 2024 — 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.

• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A WEB PAS CLINICAL STUDY, THE PATIENT HAD AN INTRAPROCEDURAL ANEURYSM RUPTURE. THE INITIAL WEB DEVICE WAS INSERTED AND THEN PROMPTLY RETRACTED AS IT WAS REPLACED WITH ANOTHER SIZED WEB AT WHICH POINT THE RUPTURE OCCURRED. THE WEB WAS IMPLANTED. THE PATIENT'S HOSPITALIZATION WAS PROLONGED. SEVEN DAYS POST-OPERATIVE, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THERE IS NO OTHER ACTION TAKEN BESIDES IMPLANTING WEB. THE PATIENT CONDITION WAS REPORTED AS MRS CHANGED FROM 0 TO 1.

  Patient problems: Ruptured Aneurysm

  MAUDE report 19038959 ↗

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.