WEB Aneurysm Embolization System W2-10-6-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429107263), received between Feb 2, 2026 and Feb 2, 2026 — 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.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE WEB PAS STUDY: ANEURYSM RECURRENCE WITH RETREATMENT. THIS EVENT IS RELATED TO THE DEVICE. STUDY: (B)(6). SUBJECT: (B)(6). EVENT #: 2 EVENT TERM: ANEURYSM RECURRENCE WITH RETREATMENT. EVENT START DATE: 16-DEC-2025. WAS THIS A SERIOUS AE? YES. ADDITIONAL INFORMATION: NOTIFICATION DATE: 14JAN2026. AN UPDATE REGARDING WEB-35-003. THIS PARTICIPANT TARGET ANEURYSM WAS RETREATED (EMBOLIZATION PERFORMED) ON (B)(6) 2026 SINCE THE 12M FU IMAGING ON (B)(6) 2025 SHOULD ANEURYSM RECURRENCE AND A TE OF WEB DEVICE COMPRESSION.

  Patient problems: Aneurysm

  MAUDE report 24242456 ↗

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.