WEB Aneurysm Embolization System W4-5-3-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429106990), received between Jan 23, 2021 and Jun 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2021Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

  IT WAS REPORTED THAT AN INTRASACCULAR FLOW DISRUPTION DEVICE (WEB SL) WAS USED FOR TREATMENT OF A BASILAR APEX ANEURYSM. AFTER SUCCESSFUL DEPLOYMENT, THE WEB WOULD NOT DETACH AND SEPARATE FROM THE DELIVERY WIRE WHEN THE DETACHMENT CONTROLLER WAS ACTIVATED. THE WEB DETACHED SUCCESSFULLY AFTER MANIPULATION OF THE DELIVERY WIRE USING PUSH/PULL TECHNIQUE. REPORTEDLY, A SLIGHT PROXIMAL REPOSITION OF THE WEB DEVICE AT THE ANEURYSM NECK WAS NOTED, WHICH RESULTED IN GREATER THAN 50% COVERING OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA). AN INTRALUMINAL SUPPORT STENT DEVICE (LVIS JR) WAS SUCCESSFULLY DEPLOYED, WHICH PROVIDED OPTIMUM COVERAGE AT THE NECK BY PUSHING THE WEB DEVICE PROTRUSION BACK INTO THE ANEURYSM. THE LEFT PCA WAS FULLY PATENT. THE PATIENT WAS REPORTED TO BE "STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971298 ↗
• InjuryJan 23, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DETACHMENT OF THE WEB IN AN ACOM ANEURYSM, THE MICROCATHETER AND THE WEB WERE INADVERTENTLY PULLED OUT OF THE ANEURYSM AND THE WEB DETACHED AT THE RIGHT ICA/MCA BIFURCATION. THE WEB WAS SUCCESSFULLY SECURED TO THE VESSEL WALL AT THE BIFURCATION WITH TWO STENTS. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS CURRENTLY REPORTED TO BE RECOVERING AND HAS NO DEFICITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219969 ↗

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.