WEB W5-5-S-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429110874), received between Jan 26, 2022 and Jan 10, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE WEB PAS CLINICAL TRIAL THAT A PATIENT WHO WAS TREATED WITH A WEB DEVICE EXPERIENCED A SUSPECTED TRANSIENT ISCHEMIC ATTACK 286 DAYS POST PROCEDURE AND LEFT SIDED WEAKNESS 293 DAYS POST PROCEDURE. THE PATIENT PRESENTED TO ED WITH ACUTE ONSET OF LEFT SIDED NUMBNESS AND WEAKNESS ON DAY 286 POST PROCEDURE. THE PATIENT¿S LEFT SIDE HAD BECOME FLACCID AT WORK WITH NO SENSATION. THEIR SYMPTOMS RESOLVED EN ROUTE TO ED WITH EMS. THEY WERE GIVEN 60MG EFFIENT LOADING DOSE WITH 10MG MAINTENANCE. THE PATIENT DID NOT TAKE THE MEDICATION DUE TO THE COST. THEN, 293 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED SUDDEN ONSET OF LEFT-SIDED WEAKNESS THAT RESOLVED BY THE TIME EMS ARRIVED. MRI DONE 10/23 REVEALED NO EVIDENCE OF STROKE. THE PATIENT WAS PRESCRIBED PLAVIX. THE OUTCOMES OF THE EVENTS IS CONSIDERED TO BE ¿RECOVERED/RESOLVED.¿

  Patient problems: Muscle Weakness/Atrophy; Numbness; Transient Ischemic Attack

  MAUDE report 21126890 ↗
• InjurySep 4, 2024Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: WEB DETACHMENT ZONE BENT UPON INSERTING INTO DETACHER. MULTIPLE DETACHER'S ATTEMPTED, ALWAYS RED LIGHT, TRIED 9V BATTERY WITHOUT SUCCESS. ATTEMPTED TO RECAPTURE WEB, WAS ABLE TO RECAPTURE HALF AND THEN FELT IT DETACH. THIS DID LEAD TO SLIGHT COMPACTION OF DEVICE. THERE WAS NO INTERVENTION NEEDED DUE TO THIS EVENT NOR WAS THERE ANY HARM TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141409 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WEB SL DEVICE WAS USED IN A PATIENT TO TREAT AN UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE PATIENT HAD VERY DIFFICULT TORTUOUS ANATOMY. THE WEB WAS INTRODUCE IN THE VIA-17 MICROCATHETER IN NORMAL FASHION AND ADVANCED INTO THE ANEURYSM. REPORTEDLY, THE PHYSICIAN DID NOT HAVE GREAT 1:1 WHEN THE WEB WAS UP AND WEB AND MICROCATHETER (SYSTEM) ADVANCED DISTAL UPON UNSHEATHING. THE SYSTEM WAS BROUGHT BACK AND THE WEB DEPLOYED IN THE ANEURYSM. SUBSEQUENT ANGIOGRAPHY RUN DEMONSTRATED CONTRAST EXTRAVASATION OUTSIDE ANEURYSM DOME. THE DECISION MADE TO DETACH THE WEB, WHICH DETACHED WITHOUT ISSUE. THE VIA CATHETER WAS BROUGHT BACK INTO THE ANEURYSM AND 3 COILS WERE DEPLOYED ALONGSIDE THE WEB. DELAYED ANGIOGRAPHY RUNS SHOWED NO FURTHER EXTRAVASATION AND THE PROCEDURE WAS CONCLUDED. PATIENT EXTUBATED POST PROCEDURE IN STABLE CONDITION AND WAS NEUROLOGICALLY INTACT; AND WAS DISCHARGED HOME.

  Patient problems: Ruptured Aneurysm

  MAUDE report 18590770 ↗
• MalfunctionMay 20, 2023Material Twisted/Bent; Activation Failure; Premature Separation; Material Twisted/Bent; Activation Failure; Premature Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970556 ↗
• InjuryJan 26, 2022Activation Problem; Difficult or Delayed Separation; Activation Problem; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE WAS USED FOR TREATMENT OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM MEASURING W-4.01 AND H-4.24 NECK-2.65. PRU WAS A 6. THE DEVICE WAS DEPLOYED BUT IT WOULD NOT DETACH USING 2 DETACHMENT CONTROLLERS. WHEN THE PHYSICIAN PULLED BACK THE MICROCATHETER BEFORE 2ND TRY ON DETACHER, THE WIRE PUSHED FORWARD. THE PHYSICIAN NEEDED TO REPOSITION THE DEVICE BUT IT PULLED OUT OF THE ANEURYSM AND SITTING IN THE BIFURCATION. PART OF THE WEB WAS RE-SHEATHED BUT DETACHED AND WAS NOT VISIBLE. ATTEMPT TO RECAPTURE THE DEVICE WAS UNSUCCESSFUL AND IT PUSHED MORE DISTAL IN THE M1. THE DECISION WAS MADE TO USE A STENT IN THE INFERIOR BRANCH AND TRAP THE DEVICE. A SECOND WEB DEVICE WAS SUCCESSFULLY DEPLOYED AND DETACHED AND FLOW WAS STEADY THROUGHOUT THE PROCEDURE. PATIENT WOKE UP NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359488 ↗

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.