WEB W5-4.5-3-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429110805), received between Nov 19, 2022 and Feb 25, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION WAS RECEIVED. PLEASE SEE H6 AND H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465123 ↗
• MalfunctionDec 12, 2024Separation Failure; Separation Failure

  AS REPORTED, THE CASE WAS A BI-LATERAL TREATMENT. THE FIRST SIDE WITHOUT INCIDENT. THE SECOND SIDE ANEURYSM TREATED HAD A BLEB AT THE ANEURYSM NECK. THE FIRST WEB WAS REPORTED TO NOT DETACH AND WAS REMOVED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921264 ↗
• InjuryOct 30, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION PROVIDED INDICATED, POST REMOVAL OF THE NON DETACHING WEB, CHANGED SIZES AND IN DOING SO THE MICROCATHETER WAS THEN MOVED INTRA-ANEURYSMALLY WITH NO WIRE BY THE PHYSICIAN CHANGING THE ORIENTATION OF THE DELIVERY OF A WEB. IT IS UNCLEAR AS TO WHETHER THE CATHETER OR THE WEB RUPTURED THE ANEURYSM. A NEW WEB OF A LARGER SIZE WAS PUSHED WITH FORCE DURING UNSHEATHING AND UPON COMPLETING THE FIRST RUN AFTER THE ORIGINAL REMOVAL OF THE NON DETACHED WEB, ACTIVE EXTRAVASATION WAS OBSERVED AND DEPLOYED THE WEB TO TAPENADE THE BLEEDING AND COILED THE ANEURYSM WITH STRYKER TARGET COILS. THE PATIENT HAS A LARGE BLEED AND IS STILL IN THE HOSPITAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 20575546 ↗
• InjuryNov 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING TREATMENT OF AN ANEURYSM RUPTURE, A WEB WAS PLACED INTO A WIDE NECK ANEURYSM. UPON DEPLOYMENT OF THE WEB, THE ANEURYSM STARTED TO BLEED. A SCEPTER BALLOON WAS USED TO CONTROL THE BLEEDING. THEN AN LVIS JR. WAS USED TO ASSIST THE WEB FURTHER INTO THE ANEURYSM. A CORONARY BALLOON WAS USED TO POST PROCESS THE STENT TO OPPOSE WALL BETTER. THE PHYSICIAN IS NOT BLAMING THE PRODUCT FOR ANY OF THE ISSUES. THE DEVICE WAS IMPLANTED IN THE PATIENT. THE PATIENT UNDERWENT A CRANIOTOMY LATER THE SAME DAY. IT WAS REPORTED THAT THE PATIENT WAS STILL IN HOSPITAL.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15830598 ↗

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.