WEB W5-7-S-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429110966), received between Mar 28, 2025 and Mar 28, 2025 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: WEB IMPINGEMENT INTO PARENT VESSEL. "A 7MM WEB SLS DEVICE INSIDE THE ANEURYSM SAC. A CONTRAST INJECTION AFTER INITIAL DEPLOYMENT SHOWED COMPLETE OCCLUSION OF THE ANEURYSM WITH MILD ENCROACHMENT ONTO THE PARENT ARTERY (SERIES 4). GIVEN THIS, WE PROCEEDED TO DETACH THIS DEVICE. A POST-DETACHMENT CONTRAST INJECTION SHOWED THAT THE PROXIMAL ASPECT OF THE WEB DEVICE HAD HERNIATED PROXIMALLY AND NOW COVERED THE RIGHT M2 SEGMENT, WITH APPROXIMATELY 90% PROTRUSION (SERIES 5). GIVEN THIS FINDINGS, WE PROCEEDED TO MANIPULATE THE WEB DEVICE WITH THE [ ] MICROWIRE, IN AN ATTEMPT TO GET MORE BRAIN INSIDE THE ANEURYSM. A REPEAT CONTRAST INJECTION AFTER THIS MANEUVER SHOWED THAT THERE WAS LESS PROTRUSION ONTO THE M2 SEGMENT (80%, SERIES 6). AT THIS JUNCTURE, WE REMOVED THE [ ] MICROCATHETER FROM THE CIRCULATION AND PROCEEDED TO ADMINISTERED A 40MG PROTAMINE BOLUS TO REVERSE THE HEPARIN ADMINISTERED. AFTER A 5 MINUTE WAITING PERIOD, A REPEAT ANGIOGRAM DEMONSTRATED NO MOVEMENT OF THE WEB DEVICE AND FLOW THROUGH THE BRAIN TO SUPPLY THE M2 BRANCH WITH 80% PARENT ARTERY PROTRUSION (SERIES 7)." TREATMENT FOR THE ¿WEB IMPINGEMENT INTO PARENT VESSEL¿ WAS MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719776 ↗

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.