WEB Aneurysm Embolization System W2-11-7-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429107317), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 16, 2022Migration; Migration

  IT WAS REPORTED THAT A WEB MIGRATED DISTALLY POST DEPLOYMENT IN THE AV FISTULA WHILE TRYING TO SHUT DOWN THE VESSEL. THE DEVICE REMAINS IMPLANTED. NO SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT IS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442479 ↗

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.