WEB Aneurysm Embolization System W4-7-4-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429107096), received between Mar 17, 2021 and Jul 12, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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 16, 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.

• MalfunctionJul 12, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE WEB DEVICE WAS POSITIONED BUT WOULD NOT DETACH WITH MULTIPLE DETACHMENT ATTEMPTS WITH THE DETACHMENT CONTROLLER. THE DEVICE WAS WITHDRAWN FROM THE PATIENT AND THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS REPORTED TO BE NORMAL AND THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727621 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACA) ANEURYSM WAS TREATED WITH A WEB DEVICE. THE DEVICE WAS IMPLANTED WITH NO ISSUES, AND CONTROL ANGIOGRAMS SHOWED NO FLOW DELAY IN THE EITHER ACA. AN ANTERIOR FRONTAL M3 BRANCH WAS THEN FOUND TO BE OCCLUDED. INTRA-ARTERIAL TPA 4MG WAS ADMINISTERED AND A STENT RETRIEVER WERE USED, AND RECANALIZATION WAS ACHIEVED. THE PATIENT HAD NOT BEEN HEPARINIZED FOR 20 MINUTES DURING IMPLANTATION OF THE DEVICE AS THE ACT MACHINE WAS BROKEN AND A NEW ONE HAD TO BE RETRIEVED. 7 HOURS POST-PROCEDURE, THE PATIENT VOMITED AND WAS CONFUSED. A CT SHOWED A LEFT FRONTAL HEMATOMA, CAUSED BY THE IA TPA AND MICROWIRE MANIPULATION, AND ALSO INDICATION OF BILATERAL DISTAL ACA STROKE. IT IS THE PHYSICIAN'S OPINION THAT THE CLOT IN THE M3 WAS MOST LIKELY NOT ASSOCIATED WITH THE WEB DEVICE, BUT THE THAT THE BILATERAL ACA STROKES WERE MOST LIKELY CAUSED BY MICRO-EMBOLI FROM THE PROXIMAL SURFACE OF THE DEVICE. IT WAS RELATED THAT THE PATIENT IS NOW IN A LONG TERM ACUTE CARE FACILITY AND HAS "RESUMED MODIFIED ORAL DIET AND HAS STARTED SAYING A FEW WORDS. STILL IS DEPENDENT ON NURSING CARE FOR ACTIVITIES OF DAILY LIVING."

  Patient problems: Confusion/ Disorientation; Hematoma; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus; Vomiting

  MAUDE report 11509913 ↗

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.