WEB Aneurysm Embolization System W2-11-9-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429107331), received between Mar 10, 2023 and Nov 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryNov 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS OBTAINED FROM THE PHYSICIAN STATING THAT THE PATIENT HAS BEEN PLACED ON COMFORT CARE.

  Patient problems: Status Epilepticus; Swelling/ Edema

  MAUDE report 23564224 ↗
• InjuryMar 10, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A SUBARACHNOID HEMORRHAGE (SAH), THE PHYSICIAN WAS GAINING ACCESS, HE REALIZED THAT IT WAS ¿TIGHT¿ AND THE CATHETER WAS HITTING ONE OF THE VESSEL WALLS, SO HE PULLED IT OUT. ONCE HE GAINED ACCESS TO THE ANEURYSM, HE BEGAN DEPLOYMENT OF THE WEB. WHEN FULLY DEPLOYED, THE WEB DEVICE WAS SHAPED LIKE AN HOURGLASS, SO AN ATTEMPT TO MASSAGE THE WEB WAS MADE, AND ONE SIDE OF THE HOURGLASS FILLED OUT AS A NORMAL WEB, BUT THE OTHER SIDE STAYED INDENTED. THE PHYSICIAN ATTEMPTED TO RE-SHEATH AND RE-POSITION; HOWEVER, IT WAS ONLY PARTIALLY RE-SHEATHED WHERE IT WAS STILL ¿FLOWERED¿ AND SOFT AT DOME. THE PHYSICIAN WAS ABLE TO DEPLOY THE WEB, BUT AGAIN HAD AN HOURGLASS FIGURE. THE PHYSICIAN WAS PLEASED WITH THE NECK AND DOME COVERAGE BUT WANTED TO HAVE THE ENTIRE WEB FILL THE ANEURYSM. MULTIPLE ATTEMPTS WERE MADE TO RE-SHEATH AND DEPLOY THE WEB RESULTED IN A CONTINUED HOURGLASS FORMATION. THE PHYSICIAN WAS ADVISED THAT DUE TO SIZE OF THE WEB, A SIGNIFICANT AMOUNT OF FORCE WAS REQUIRED TO RE-SHEATH, AND ATTEMPTED TO USE A TORQUE DEVICE TO ADD FORCE BUT STILL UNABLE TO COMPLETELY SHEATH. ONCE THE PHYSICIAN DECIDED TO NO LONGER ATTEMPT RE-SHEATHING, HE THEN

  Patient problems: Clinical Endoleak

  MAUDE report 16526577 ↗

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.