WEB Aneurysm Embolization System W2-9-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00856956005985), received between Aug 30, 2019 and Aug 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.

• MalfunctionAug 30, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A WEB DEVICE WAS SUCCESSFULLY DETACHED WITHIN AN ANEURYSM, BUT THE PUSHER WIRE WAS ADVANCED FORWARD, INVAGINATING THE WEB DEVICE AND PUSHING IT CLOSER TO THE DOME OF THE ANEUYSM. A SNARE WAS USED TO PULL THE WEB BACK INTO PLACE. THERE WAS NO REPORTED ADVERSE CLINICAL SEQUELA TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8952735 ↗

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.