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

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00842429110928), received between Jun 3, 2022 and Apr 24, 2025 — classified as 1 death, 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• DeathApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: A WEB 7X3 WAS SUCCESSFULLY IMPLANTED INTO A PREVIOUSLY HIGH GRADE RUPTURED (X2) ANEURYSM. CONTRAST STASIS WAS OBSERVED IN THE ANEURYSM AND THE WEB SHOWED GOOD COMPRESSION. NO ENCROACHMENT ON BRANCH VESSELS AND POST ANGIO IMAGES LOOKED GOOD. THE PROCEDURE CONCLUDED AND THE PATIENT LEFT THE ANGIO SUITE. AT SOME POINT LATER THAT NIGHT OR EARLY MORNING THE HEMATOMA HAD EXPANDED AND THE RUPTURED ANEURYSM REBLED. NO FURTHER SURGICAL INTERVENTIONS WERE PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21904325 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY, SIGNIFICANT AMOUNT OF SACCULAR RECANALIZATION AND DEVICE COMPACTION REQUIRING RETREATMENT. A CAUSAL RELATIONSHIP TO THE STUDY DEVICE IS STATED. PATIENT HAD RT PROCEDURE ON (B)(6) 2025. NO AES WERE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 21370860 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: IMAGING CONFIRMED THE PRESENCE OF A SMALL RESIDUAL BASE AT THE BASILAR TIP ANEURYSM, APPROXIMATELY A MONTH AFTER THE INDEX PROCEDURE. PATIENT REQUIRED A RETREATMENT WITH FLOW DIVERTER DUE TO THE RESIDUAL ANEURYSM FILLING. PATIENT HAS RECOVERED, MRS AT BASELINE WAS 3 AND MRS AFTER RETREATMENT WAS 2. THE EVENT WAS DETERMINED AS POSSIBLY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20262101 ↗
• MalfunctionSep 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED, DURING PREPARATION OF THE WEB DEVICE, WHILE IT WAS BEING DEPLOYING IN THE BOWL OF SALINE, IT WAS NOTICED THAT THE DEVICE HAD A SLIGHT NARROWING (WAIST) IN THE MIDDLE SECTION. WHEN THE DEVICE WAS RETRACTED AND THEN EXPOSED AGAIN, THE NARROWING HAD RECOVERED HOWEVER IT STILL DID NOT LOOK ¿NORMAL¿. THE PHYSICIAN ASKED FOR A NEW DEVICE WHICH WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. ADDITIONAL INFORMATION FROM THE POST-EVALUATION REPORT REVEALED THAT THE RETURNED WEB SYSTEM WAS FOUND TO HAVE BROKEN WIRES ON THE WEB IMPLANT, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EXPANSION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208853 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A WEB PAS CLINICAL STUDY, THE PATIENT HAD AN INCREASED RESIDUAL ANEURYSM. RETREATMENT IS BEING CONSIDERED. THE AE OUTCOME IS ONGOING. THE RELATIONSHIP TO THE STUDY DEVICE, INDEX ENDOVASCULAR PROCEDURE, STUDY DISEASE, AND CONCOMITANT DISEASE ARE ALL POSSIBLE. THE PATIENT IS ASYMPTOMATIC.

  Patient problems: Aneurysm

  MAUDE report 19716749 ↗
• InjuryJun 27, 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 A NON-OCCLUSIVE PLATELET PLUG WAS SEEN AT BASE OF WEB DEVICE WHICH WAS TREATED WITH INTEGRILIN. THE SUBJECT WAS ASYMPTOMATIC. THE OUTCOME WAS REPORTED AS "RECOVERED/RESOLVED."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19621470 ↗
• InjuryJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE WEB PAS CLINICAL STUDY THAT A PORTION OF A WEB DEVICE IMPLANTED TO TREAT AN ANEURYSM WAS OVERHANGING INTO THE INFERIOR PARENT ARTERY. A STENT WAS IMPLANTED TO COMPLETE COMPLETE PATENCY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445054 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE WEB PAS CLINICAL STUDY: PATIENT UNDERWENT REINTERVENTION OF TARGET ANEURYSM, WITH FLOW DIVERTER PLACED. A WEEK LATER, PATIENT PRESENTS TO OUTSIDE HOSPITAL REPORTING MEMORY LOSS. PATIENT WAS DISCHARGED TWO DAYS LATER ONLY TO RETURN TO THE HOSPITAL THE NEXT DAY WITH CONFUSION. AFTER TRANSFERRING TO A DIFFERENT HOSPITAL, THE PATIENT REPORTS FEELING NORMAL. CT SHOWS HYPODENSITY IN THE LEFT CAUDAL THALAMIC AREA OF A RECENT INFARCT. MRI/MRA SHOWS A SMALL AREA OF RECENT INFARCT INVOLVING THE LEFT CAUDOTHALAMIC REGION AND ADJACENT FORNIX. THE PATIENT WAS NOTED TO BE ORIENTED AND HAD NO ACUTE COMPLAINTS THE NEXT DAY. PATIENT UNDERWENT WEB IMPLANTATION A YEAR PRIOR TO THE REINTERVENTION OF TARGET ANEURYSM WITH THE FLOW DIVERTER. IT WAS REPORTED BY THE CLINICAL STAFF THAT THERE IS A POSSIBLE RELATIONSHIP OF THE STUDY DEVICE TO THE REPORTED ADVERSE EVENT. PATIENT HAS A HISTORY OF HYPERTENSION, OPEN WOUND OF FINGERS, CENTRAL SEROUS RETINOPATHY AND IS A CURRENT SMOKER.

  Patient problems: Confusion/ Disorientation; Memory Loss/Impairment

  MAUDE report 19337675 ↗
• MalfunctionMar 19, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE WEB DEVICE DIDN¿T DETACH. AFTER MULTIPLE ATTEMPTS WITH THE DETACHER TO DETACH THE DEVICE UNSUCCESSFULLY THE WEB WAS RECAPTURED AND REMOVED FROM THE PATIENT. THE WEB DID DETACH IN THE CATHETER ON REMOVAL AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A SECOND DEVICE WAS SUCCESSFULLY USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938036 ↗
• MalfunctionNov 9, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE WAS USED TO TREAT A PATIENT WITH A MCA BIFURCATION ANEURYSM. AFTER DEPLOYMENT, THE WEB DEVICE DID NOT DETACH AFTER MULTIPLE ATTEMPTS WITH THE DETACHMENT CONTROLLER. CONTROLLER WAS TESTED FOR FUNCTIONALITY PRIOR TO INTRODUCING AND SUBSEQUENTLY IMPLANTING THE DEVICE. THE PHYSICIAN ADVANCED THE MICROCATHETER AND MECHANICALLY DETACHED THE WEB DEVICE FOR SUCCESSFUL IMPLANTATION. NO REPORT OF HARM OR INJURY TO THE PATIENT, WHO WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108058 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED. PLEASE SEE H6 AND H10.

  Patient problems: Aneurysm

  MAUDE report 18107943 ↗
• InjuryMay 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED IN WEB PAS CLINICAL TRIAL, A PATIENT WITH NO SIGNIFICANT HISTORY FOUND TO HAVE A 6MM INCIDENTAL ACOM ANEURYSM. A WEB SL WAS IMPLANTED; HOWEVER, POST PROCEDURE, THE PATIENT DEVELOPED APHASIA, GLOBAL LETHARGY AND RIGHT ARM DRIFT. THE PATIENT RETURNED TO THE OR AND ANGIOGRAPHY SHOWED THE WEB SL DEVICE WAS UNSTABLE. REPORTEDLY, THE PHYSICIAN RETRIEVED THE WEB DEVICE AND PLACED ANOTHER. THE PATIENT HAD NO SPASM OR ACUTE STROKE ON CT AND EEG WAS IN PROGRESS.

  Patient problems: Fatigue; Speech Disorder

  MAUDE report 16989775 ↗
• InjuryMar 8, 2023Dent in Material; Difficult or Delayed Separation; Dent in Material; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE WAS USED TO TREAT A PATIENT WITH A BASILAR ALEX ANEURYSM. REPORTEDLY DURING DEPLOYMENT, THERE WAS DELAYED DETACHMENT AND THE WEB DETACHED AFTER MULTIPLE ATTEMPTS WITH THE DETACHMENT CONTROLLER THAT RESULTED IN INDENTATION ON THE WEB. A SNARE DEVICE WAS USED TO CORRECT THE INDENTATION ON THE WEB, WHICH WAS DEPLOYED IN INTENDED LOCATION. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT, WHO WAS FINE. ADDITIONAL INFORMATION RECEIVED. THE CASE FOR TREATING A BASILAR ALEX ANEURYSM. PHYSICIAN WAS TRYING TO DETACH WEB FROM PUSHER WIRE RESULTED IN AN INDENTATION. TRIED TO DETACH IT 4X AND OUR DETACHMENT DEVICE FAILED 3X. PATIENT ANATOMY WAS EXTREMELY STRAIGHT FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507411 ↗
• InjuryJan 11, 2023Dent in Material; Separation Failure; Dent in Material; Separation Failure

  IT WAS REPORTED THAT A WEB DEVICE WAS ATTEMPTED TO BE IMPLANTED IN AN ANEURYSM AND WOULD NOT DETACH AFTER MULTIPLE DETACHMENT ATTEMPTS WITH THREE DIFFERENT DETACHMENT CONTROLLERS. THE DEVICE WAS DETACHED BY INVAGINATING THE DEVICE IN THE ANEURYSM. THE PROXIMAL RECESS OF THE ANEURYSM WAS COILED. THE PATIENT WAS UNHARMED AND WAS DISCHARGED SAME DAY WITHOUT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143324 ↗
• InjuryJan 8, 2023Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

  IT WAS REPORTED THAT WHEN THE WEB DEVICE WAS DELIVERED TO THE ACOM ANEURYSM, IT WAS ATTEMPTED TO BE DETACHED IN AN INNIE SHAPE DUE TO THE HEIGHT WAS SLIGHTLY TOO LONG. AFTER SEVERAL FAILED ATTEMPTS, THE VIA CATHETER WAS PUSHED UP TO THE WEB'S PROXIMAL MARKER TO PUSH IT OFF. AFTER THE DEVICE DETACHED, IT APPEARED TO BE PROTRUDING OUT OF THE ANEURYSM. THE POST ANGIO SHOWED SLOW FLOW AND THE OCCLUSION OF THE A2. AN ATTEMPT WAS MADE TO USE A STENT ACROSS THE WEB TO PUSH IT INTO THE ANEURYSM; HOWEVER IT FAILED. PHARMACOLOGICAL TREATMENT WAS PROVIDED TO THE PATIENT. NO FURTHER INTERVENTION IS PLANNED AS THE STENT ATTEMPT FAILED. THE PATIENT WAS SENT HOME THREE DAYS POST WEB IMPLANTATION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16118953 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A TREATMENT OF A BASILAR APEX ANEURYSM WITH A WEB DEVICE, PLACEMENT WAS DIFFICULT AND DURING MULTIPLE REPOSITIONING ATTEMPTS, THE ANEURYSM WAS RUPTURED. THE ANEURYSM WAS MEASURED, AND A 8X3 WEB DEVICE WAS CHOSEN. THE DEVICE WAS DEPLOYED AND ENCROACHED ON THE RIGHT PCA. THE 8X3 WEB DEVICE WAS REMOVED AND A 7X3 WEB DEVICE WAS SELECTED. THE WEB DEVICE WAS DEPLOYED AND ENCROACHED ON THE RIGHT PCA. THE DEVICE WAS REMOVED AND AN ANGLED VIA 17 DEVICE WAS POSITIONED WITHIN THE ANEURYSM. THE SAME WEB DEVICE WAS THEN ATTEMPTED TO BE DEPLOYED FOR THE SECOND TIME, HOWEVER THE DEVICE WAS STILL ENCROACHING ON RIGHT PCA. BOTH THE WEB AND VIA DEVICES WERE REMOVED AND A DIFFERENT ANGLE CATHETER (90 ANGLE) WAS CHOSEN TO GET A BETTER POSITION WITHIN THE ANEURYSM. THE SAME WEB WAS REPOSITIONED A THIRD TIME, WHEN THE ANEURYSM RUPTURED. THE WEB WAS LEFT IN PLACE TO ASSIST TAMPONADE. THE PHYSICIAN INSERTED A BALLOON TO ASSIST IN CONTROLLING THE BLEED. THE BLEED WAS CONTROLLED WITH COILING AND DETACHMENT OF THE WEB. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE WEB WAS FULLY DEPLOYED OUTSIDE THE CATHETER DURING THE ANEURYSM RUPTURE. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ruptured Aneurysm

  MAUDE report 14595347 ↗

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.