WEB Aneurysm Embolization System W2-9-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00856956005855), received between Mar 29, 2022 and Mar 29, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Activation Problem” (1 report).

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.

• InjuryMar 29, 2022Difficult to Remove; Activation Problem; Difficult to Remove; Activation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF AN ACOMM ANEURYSM, A WEB DEVICE OPENED AT THE DISTAL THIRD, BUT THE PROXIMAL TWO THIRDS WERE NOT OPENED. THE WEB COULD NOT BE RESHEATED OR OPENED, AND WAS DEPLYED IN THE ANEURYSM NECK. A STENT WAS IMPLANTED TO KEEP THE A1 AND A2 OPEN. POST PROCEDURAL IMAGING REVEALED A RESIDUAL ANEURYSM, BUT FLOW TO THE PARENT VESSEL WAS OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934930 ↗

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.