WEB Aneurysm Embolization System W2-8-5-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429107164), received between Jun 21, 2024 and Jan 15, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ANEURYSM RUPTURED WHILE DEPLOYING THE WEB. AN EVD WAS PLACED. THE PATIENT WAS EXTUBATED AND FOLLOWING COMMANDS. THE PATIENT IS SLOWLY IMPROVING.

  Patient problems: Ruptured Aneurysm

  MAUDE report 24090174 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THRU THE WEB PAS CLINICAL STUDY: EVENT START DATE: 16-MAY-2024 POST OPERATIVE DAYS: 207. EVENT DESCRIPTION: DATE OF ORIGINAL SURGERY WAS (B)(6) 2023 - AT THE 6-MONTH VISIT THE AREA OF RESIDUAL ANEURYSM CLOSE TO THE NECK APPEARS TO HAVE INCREASED DUE TO MIGRATION OF THE WEB FURTHER INTO THE DOME OF THE ANEURYSM OR WEB COMPACTION. ADDITIONAL TREATMENT IS BEING CONSIDERED BUT NOT SCHEDULED OR CONFIRMED. AMOUNT OF RESIDUAL INCREASE IS NOT KNOWN. W2-8-5 SL, VIA 027 USED. NOTE: SITE QUERIED TO REPORT THE WEB COMPACTION AS A TE LEADING TO AE4. EVENT TERM: INCREASED RESIDUAL ANEURYSM LOCATION OF ANEURYSM - RUPTURED ANTERIOR COMMUNICATING ARTERY COMPLEX (GRADE 1: ASYMPTOMATIC, OR MINIMAL HEADACHE AND SLIGHT NUCHAL RIGIDITY. WAS THIS A SERIOUS AE?: NO SITE ASSESSED RELATIONSHIP TO STUDY DEVICE: POSSIBLE SITE ASSESSED RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLE RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED RELATIONSHIP TO STUDY DISEASE: POSSIBLE RELATIONSHIP TO CONCOMITANT DISEASE: POSSIBLE RELATIONSHIP TO STUDY DEVICE : CAUSAL RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLE RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED RELATIONSHIP TO STUDY DISEASE

  Patient problems: Aneurysm expansion

  MAUDE report 19580909 ↗

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.