WEB Aneurysm Embolization System W2-8-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00856956005817), received between Jul 22, 2020 and Aug 8, 2022 — classified as 1 death, 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. How this data works · Data updated Oct 13, 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.

• InjuryAug 8, 2022Unintended Movement; Difficult or Delayed Separation; Unintended Movement; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE DID NOT FULLY DETACH ON THE FIRST DETACHMENT. THE VIA CATHETER WAS ADVANCED SLOWLY, AND WEB DETACHED. THE CASE WAS REPORTED TO BE DIFFICULT BECAUSE OF THE ANATOMY AND ANGLE OF THE WAS ANEURYSM IN WITH THE VIA 27 AND CAUSED THE WEB DEVICE TO ROTATE. AS A RESULT, THE ANEURYSM HAD A SMALL RUPTURE/BLEED AFTER, WHICH WAS TREATED WITH AN INFLATED A COMPETITOR BALLOON DEVICE FOR A FEW MINUTES, AND THE BLEEDING WAS THEN STOPPED. THE PATIENT WAS MONITORED OVERNIGHT AND DID NOT RE-RUPTURE. THE PATIENT WOKE UP OKAY AND INTACT, AND REPORTED TO BE SPEAKING AND RESPONDING CONVERSATIONALLY. THE PATIENT WAS HELD AT THE HOSPITAL FOR A FEW EXTRA DAYS FOR OBSERVATION BEFORE DISCHARGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 15188175 ↗
• DeathMay 19, 2021Adverse 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 A RUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY BIFURCATION ON (B)(6) 2020 WITH GOOD OCCLUSION OF THE ANEURYSM AND STAGNATE FLOW IN THE SAC. THE PATIENT WAS EVALUATED ONE MONTH POST-OP AND THE ANEURYSM DID NOT SHOW UP ON MRA. THE ANEURYSM WAS DETERMINED TO BE OCCLUDED. AT THREE MONTHS POST-OP, THE PATIENT DEVELOPED EYE PAIN. IMAGING REVEALED THE ANEURYSM HAD GROWN SIGNIFICANTLY, THE ANEURYSM APPEARED TO HAVE SIGNIFICANT FILLING IN THE NECK AND BASE OF THE ANEURYSM SAC, AND THE WEB WAS COMPACTED INTO THE DOME. THE PATIENT EXPERIENCED ACUTE SYMPTOMS WAS DIAGNOSED WITH A LARGE SUBDURAL HEMATOMA AND SUBARACHNOID HEMORRHAGE. THE PATIENT LATER PASSED AWAY.

  Patient problems: Eye Pain; Intracranial Hemorrhage

  MAUDE report 11853150 ↗
• InjuryJul 22, 2020Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Difficult to Remove; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM. AFTER PLACEMENT OF THE WEB IN THE ANEURYSM, THE WEB DID NOT DETACH AFTER TWO (2) ATTEMPTS. THE WEB APPEARED TO HAVE DETACHED WITH THE THIRD ATTEMPT; HOWEVER, WHEN THE PUSHER WIRE AND MICROCATHETER WERE REMOVED, THE WEB WAS PULLED OUT OF THE ANEURYSM AND THEN DETACHED IN THE INTERNAL CAROTID ARTERY (ICA). THE WEB WAS REMOVED FROM THE ICA WITH A STENT RETRIEVER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO HAVE NO DEFICIENCIES THE DAY AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312043 ↗

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.