WEB Aneurysm Embolization System W2-9-4-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842429107195), received between Jun 25, 2024 and Dec 5, 2025 — classified as 1 death, 4 injuries, 2 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

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

  SEE H11.

  Patient problems: Extravasation

  MAUDE report 23735553 ↗
• InjuryNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE WEB WAS PREPPED ON THE BACK TABLE, PULLED BACK INTO THE SHEATH TO INTRODUCE SALINE. THEN PUSHED OUT SLOWLY INTO A BOWL OF SALINE AND CHECKED FOR BUBBLES, THEN RE-SHEATHED. THE CONTINUITY TEST WAS PERFORMED ON THE WEB AND PASSED AS A GREEN LIGHT APPEARED. THE WEB WAS BACKFLUSHED AND THEN INTRODUCED INTO THE VIA 27 AND PUSHED SMOOTHLY IN THE MICROCATHETER. THE VERTEBRAL ARTERY HAD MODERATE TORTUOSITY, AND A KINK WAS CREATED IN THE PUSHER WIRE WHILE ADVANCING, DOUBLE CHECKED WITH THE DETACHER, A GREEN LIGHT STILL APPEARED, AND THE DETACHMENT BUTTON WAS NOT PUSHED. ADVANCED THE WEB THROUGH VIA 27. UPON FIRST DEPLOYMENT OF THE WEB, THE PUSHER WIRE WAS PULLED BACK TO TRY TO MANIPULATE THE DEVICE AND THE WEB DETACHED FROM PUSHER WIRE. PLACED A STENT TO KEEP RIGHT PCA OPEN. PATIENT CONDITION/OUTCOME, STABLE, NEURO STATUS BASELINE. ADDITIONAL CLARIFYING INFORMATION RECEIVED INDICATED, THE WEB DETACHED AT THE DETACHMENT ZONE AS INTENDED. IT JUST DETACHED WITHOUT THE CONTROLLER BEFORE WE WERE READY TO DETACH. IT DETACHED IN A GOOD POSITION BUT NOT IN THE INTENDED POSITION AND REMAINS IMPLANTED. THE PHYSICIAN WANTED TO DO SOME MANIPULATION TO POSSIBLY IMPROVE THE POSITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601376 ↗
• MalfunctionOct 27, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED, THE WEB DID NOT DETACH, HAD STICKY DETACHMENT. A WDC-2 HANDLE WAS ATTEMPTED MULTIPLE TIMES WITH GREEN LIGHT FOR CONNECTION. THE PHYSICIAN MANIPULATED THE VIA 27 MICROCATHETER UP TO THE PROXIMAL MARKER OF THE WEB AND THEN UNSHEALTHED. THE WEB WIRE WAS GENTLY PULLED ON, AND BECAME DETACHED MANUALLY. PATIENT WOKE UP, ANEURYSM WAS SECURED, WEB STAYING IN PLACE IN THE ANEURYSM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399257 ↗
• MalfunctionJul 28, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DETACHMENT WAS ATTEMPTED NUMEROUS TIMES; HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS "RETURN TO BASELINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22634652 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY, EVENT #3. EVENT TERM: WEB COMPACTION, ADDITION OF STENT AND COIL. NO TECHNICAL EVENT REPORTED. THE RELATIONSHIP TO THE STUDY DEVICE IS REPORTED AS PROBABLE. RELATIONSHIP TO STUDY DISEASE IS REPORTED AS POSSIBLE. AE OUTCOME: RECOVERED/RESOLVED. DATE OF RESOLUTION: (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079668 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY WEB PAS: EVENT INFORMATION : EVENT TERM : TRANSIENT VISION CHANGES EVENT #: 2 EVENT START DATE: 18-DEC-2023 POST OPERATIVE DAYS: 0 EVENT DESCRIPTION : THE PATIENT REPORTS SOME HEADACHES AND TRANSIENT VISION CHANGES SINCE THE PROCEDURES. SITE ASSESSED RELATIONSHIP TO STUDY DEVICE : NOT RELATED SITE ASSESSED RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLE RELATIONSHIP TO USE OF ANCILLARY DEVICE : NOT RELATED RELATIONSHIP TO STUDY DISEASE : NOT RELATED RELATIONSHIP TO CONCOMITANT DISEASE : POSSIBLE AE OUTCOME : ONGOING CEC ASSESSMENT OF AE ON 13AUG2024 RELATIONSHIP TO STUDY DEVICE : POSSIBLE RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: NOT RELATED RELATIONSHIP TO STUDY DISEASE : NOT RELATED RELATIONSHIP TO CONCOMITANT DISEASE : POSSIBLE THE CEC ADJUDICATED WEB-19-003 AE2: TRANSIENT VISION CHANGES AS POSSIBLY RELATED TO THE WEB DEVICE. ALTHOUGH REQUESTED, THE STUDY SITE WAS NOT ABLE TO PROVIDE CLARIFICATION ON TYPE OF VISION CHANGES. AS OF 26AUG2024, THE STUDY SITE REPORTED THE HEADACHES AND TRANSIENT VISION CHANGES ARE ONGOING SINCE THE PROCEDURES, NO INTERVENTION IS NOTED, AND NO PATIENT UPDATE WAS MADE AVAILABLE.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 20072241 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE WEB PAS CLINICAL STUDY THAT ON POST OPERATIVE DAY (POD) 92, THE PATIENT EXPERIENCED CASES OF SYNCOPE ACCOMPANIED BY FALL. PATIENT REGAINED CONSCIOUSNESS SHORTLY AFTER AND WAS HOSPITALIZED FOR 48 HOURS. NO FURTHER INFORMATION PROVIDED. NO IMAGING WAS PERFORMED. THE PRESENTING SYMPTOMS OF SYNCOPE COULD BE RELATED TO THE TARGET ANEURYSM, WHICH WAS ON THE BASILAR APEX. HOWEVER, THE ADVERSE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE STUDY DEVICE.

  Patient problems: Syncope/Fainting

  MAUDE report 19610678 ↗

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.