WEB Aneurysm Embolization System W2-10-5-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429107256), received between Oct 27, 2023 and Nov 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE WEB INTRASACCULAR FLOW DISRUPTION DEVICE WAS USED FOR A DISTAL ICA ANEURYSM EMBOLIZATION. AFTER THE DEVICE WAS DETACHED IN THE ANEURYSM, IT WAS NOTED THAT THE SELECTED SIZE WAS TOO SMALL FOR THE ANEURYSM AND THE DEVICE ROTATED SLIGHTLY WITHIN THE ANEURYSM; HOWEVER, IT REMAINED FULLY CONTAINED WITHING THE ANEURYSM SACK. A SHORT ATTEMPT WAS MADE TO COAX THE WEB INTO A MORE COAXIAL POSITION WITHIN THE ANEURYSM, BUT IT REMAINED OUT OF POSITION. THE DECISION WAS THEN MADE TO USE HYDROGEL COILS AND PLACE THEM PROXIMALLY TO THE WEB. ONCE THE COILS WERE INTRODUCED, THE WEB ORIENTATION WAS CORRECTED AND THE ANEURYSM WAS SUCCESSFULLY TREATED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589375 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CAR STUDY, SUBJECT (B)(6) AE TERM: STROKE AE START DATE: (B)(6) 2024 WAS EVENT ASSOCIATED WITH A NEW NEUROLOGICAL DEFICIT? YES EVENT LOCATION: IPSILATERAL TO TARGET IA WAS EVENT A STROKE: YES AE DETAILS: POST SUCCESSFUL WEB EMBO OF RUPTURED R PCOM, SUBJECT WAS NOTED TO BE MOVING ALL EXTREMITIES BUT CONFUSED, THIS PROGRESSED TO PT BEING MINIMALLY RESPONSIVE W/LEFT HEM1PLEGIA. HEAD CTA OBTAINED WHICH SHOWED NEARLY OCCLUSIVE THROMBUS IN THE R ICA. RETURNED TO NIR SUITE FOR THROMBECTOMY. IR BOLUS OF INTEGRILLIN GIVEN, DIRECT ASPIRATION OF THE CLOT PERFORMED. ONLY MILD STENOSIS FROM EVENT DESCRIPTION: A SMALL AMOUNT OF ADHERENT RESIDUAL CLOT. NO FLOW IMPEDIMENT. STARTED ON DAPT AND TRANSFERRED BACK TO NEURO ICU. WAS THIS EVENT A SERIOUS ADVERSE EVENT? YES WAS AE DUE TO DEVICE DEFICIENCY? NO RELATED TO STUDY DEVICE? POSSIBLY RELATED TO INDEX ENDOVASCULAR PROCEDURE? PROBABLY RELATED TREATMENT REQUIRED? MEDICATION, MECHANICAL THROMBECTOMY AE RESOLUTION? RESOLVED WITHOUT SEQUELAE ON (B)(6) 2024.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 20635547 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WEB DEVICE WAS IMPLANTED IN AN ANEURYSM OF THE BASILAR ARTERY ON (B)(6) 2023. ON OCTOBER 11, 2023, THE PATIENT EXPERIENCED RIGHT SIDED VISION LOSS DUE TO THROMBUS LOCATED ON THE LEFT P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY. THE PATIENT WAS GIVEN EMERGENT INTEGRILIN OVERNIGHT AND HE RECOVERED. THE WEB WAS PROTRUDING, BUT LESS THAN 20% AND NOT OCCLUSIVE. NO STROKE WAS OBSERVED ON MRI AT THAT POINT.

  Patient problems: Thrombosis/Thrombus; Visual Impairment

  MAUDE report 18025204 ↗

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.