WEB W5-7-4-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429110935), received between Apr 10, 2024 and Dec 5, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ENROLLED IN THE WEB PAS CLINICAL STUDY EXPERIENCED ANEURYSM GROWTH DURING FOLLOW UP. THERE IS FILLING OF 5 MM WHEN IT WAS PREVIOUSLY 2 MM AT THE BASE. THERE HAS BEEN NO INTERVENTION AND THERE IS NO REPORTED PATIENT SEQUELAE.

  Patient problems: Aneurysm expansion

  MAUDE report 23732075 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A WEB PROCEDURE. THE ANEURYSM TO BE TREATED WAS LOCATED AT THE ACOMM ACCESS TO THE AX WAS VIA THE R INTERNAL CAROTID ARTERY. THE ANGLE OF THE A1 SEGMENT INTO THE ARTERY MADE ACCESS INTO THE AX DIFFICULT. MANIPULATION OF THE WEB WAS NECESSARY IN ORDER TO ACHIEVE PROPER PLACEMENT AND ALIGNMENT. ONCE ALIGNMENT WAS ACHIEVED, THE PHYSICIAN OBTAINED A CINE RUN WHERE EXTRAVASATION WAS NOTED. THE WEB WAS DETACHED AND MEASURES TO STOP THE EXTRAVASATION BEGAN. CONTRAST EXTRAVASATION WAS OBSERVED POST PLACEMENT, PRE-DETACHMENT OF THE WEB. THE WEB WAS IMMEDIATELY DETACHED AND THE PROCESS TO LOWER BP/HR, REVERSE HEPARIN, AND STABILIZE THE PATIENT BEGAN. PATIENT WAS SENT FOR A CT SCAN TO VISUALIZE THE EXTENT OF THE EXTRAVASATION. THE PATIENT WAS IN STABLE CONDITION AND DOING WELL.

  Patient problems: Extravasation

  MAUDE report 20802474 ↗
• MalfunctionOct 9, 2024Separation Failure; Separation Failure

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413615 ↗
• InjuryAug 12, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING TREATMENT OF AN ACOM ANEURYSM WITH A WEB DEVICE, THE WEB NEEDED TO BE REPOSITIONED. THE RESHEATING OF THE WEB WAS DIFFICULT, BUT IT WAS PLACED AGAIN, WHICH WAS SUCCESSFUL. THE WEB DEVICE REQUIRED SIX ATTEMPTS TO DETACH IT. AFTER THE DETACHMENT, A SMALL CLOT WAS OBSERVED AT THE PROXIMAL MARKER OF THE WEB. AGGRASTAT WAS ADMINISTERED. THE PATIENT WAS REPORTED TO BE ¿WELL OFF.¿

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19969329 ↗
• MalfunctionApr 10, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT AN INTRASACCULAR FLOW DISRUPTION DEVICE WAS DEPLOYED IN THE ANEURYSM AND WOULD NOT DETACH WITH A DETACHMENT CONTROLLER. THE PHYSICIAN REMOVED THE DEVICE, INSPECTED IT, RE-ACCESSED THE ANEURYSM AND DEPLOYED SAME DEVICE. IT WOULD NOT DETACH AGAIN WITH TWO DIFFERENT DETACHMENT CONTROLLERS. A NEW DEVICE WAS CHOSEN AND DETACHED SUCCESSFULLY. THERE WAS NO INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076932 ↗

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.