WEB Aneurysm Embolization System W2-8-3-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00842429107140), received between Jun 18, 2021 and Jul 1, 2026 — classified as 11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING AN ON-LABEL WIDE-NECK BIFURCATION ANEURYSM USING A WEB DEVICE. AN 8 MM × 3 MM WEB DEVICE WAS SELECTED FOR TREATMENT. DURING DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO OPTIMIZE POSITIONING BY ADJUSTING THE PARTIALLY DEPLOYED DEVICE TO IMPROVE SEATING WITHIN THE ANEURYSM DOME. THE DEVICE WAS DEPLOYED; HOWEVER, FOLLOW-UP ANGIOGRAPHY DEMONSTRATED THAT THE DEVICE WAS NOT FULLY CONTAINED WITHIN THE ANEURYSM AND SUGGESTED THE PRESENCE OF EXTRAVASATION. IT WAS REPORTED THAT ATTEMPTS TO REPOSITION THE DEVICE WERE UNSUCCESSFUL. THE DEVICE WAS LEFT IN PLACE TEMPORARILY, AND HEPARIN WAS REVERSED IN AN EFFORT TO CONTROL THE EXTRAVASATION. AFTER APPROXIMATELY 10 MINUTES, THE EXTRAVASATION RESOLVED, AND THE DECISION WAS MADE TO EXCHANGE FOR A SMALLER DEVICE. THE 8 MM × 3 MM WEB DEVICE WAS SAFELY RESHEATHED WHILE MAINTAINING ACCESS TO THE ANEURYSM. A 7 MM × 3 MM WEB DEVICE WAS SUBSEQUENTLY DEPLOYED. A SMALL AMOUNT OF EXTRAVASATION WAS AGAIN OBSERVED FOLLOWING DEPLOYMENT; THEREFORE, THE PHYSICIAN WAITED AN ADDITIONAL PERIOD PRIOR TO DETACHMENT. AFTER APPROXIMATELY 5 MINUTES, NO FURTHER EXTRAVASATION WAS OBSERVED, AND THE DEVICE WAS SUCCESSFULLY DETACHED.

  Patient problems: Extravasation

  MAUDE report 25680635 ↗
• MalfunctionAug 18, 2025Separation Failure; Separation Failure

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835300 ↗
• InjuryMay 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: TARGET ANEURYSM WAS AN UNRUPTURED BASILAR APEX ANEURYSM. A 0-50% REDUCTION IN PARENT VESSEL DIAMETER DUE TO WEB IMPINGEMENT WITH NO FLOW RESTRICTION PER DSA. THIS EVENT OCCURRED AFTER WEB IMPLANTATION AND DID NOT REQUIRE FURTHER OR ADDITIONAL TREATMENT/ACTION. PATIENT WAS ASYMPTOMATIC AND MRS REMAINED 0 AT DISCHARGE FROM INDEX PROCEDURE THROUGH TO THE 12 MONTHS FOLLOW UP VISIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070952 ↗
• InjuryJan 8, 2025Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A WEB TREATMENT OF MCA ANEURYSM, AN 8X3 WEB WAS IMPLANTED USING A MICROCATHETER. UPON DETACHMENT, THE WEB DEVICE WOULD NOT RELEASE FROM THE TETHER. THE MICROCATHETER WAS BROUGHT UP TO SUPPORT THE WEB FOR A MORE AGGRESSIVE PULL BACK ON THE DELIVERY WIRE. THE WEB EVENTUALLY DETACHED BUT SHIFTED INTO THE M2. A STENT WAS PLACED IN THE M2 TO OPEN VESSEL BACK UP. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106171 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Ischemia Stroke; Paresis; Speech Disorder

  MAUDE report 20638607 ↗
• MalfunctionMay 29, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: A WEB SL, 8X3 DEVICE WAS PREPARED BY AN EXPERIENCED USER. THE WEB WAS ADVANCED INTO A MICROCATHETER. THE WEB WAS OPENED IN A BASILAR ANEURYSM. THIS WEB DID NOT DETACH FIRST TIME WHEN THE DETACHMENT CYCLE WAS RUN ON THE DETACHMENT CONTROLLER. THE PHYSICIAN DRIED THE END OF THE WEB PUSHER WIRE AND SEATED THE PUSHER WIRE AT A 90 DEGREE ROTATION OF THE DETACHMENT CONTROLLER AND REPEATED THE DETACHMENT CYCLE USING THE DETACHMENT CONTROLLER ONCE MORE. THE MICROCATHETER WAS TRACKED FORWARD OVER THE WEB PUSHER WIRE TO MASSAGE THE PROXIMAL WEB MARKER AND DETACHMENT ZONE. THE MICROCATHETER CAUSED SPONTANEOUS MECHANICAL FRACTURE OF THE DETACHMENT ZONE. THE WEB DETACHED IN THE DESIRED ANATOMICAL LOCATION EMBOLIZING THE BASILAR ANEURYSM. PATIENT IS ALIVE AND WAS NOT AFFECTED BY THIS DEVICE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19419475 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE WEB PAS STUDY THAT A PATIENT ENCOUNTERED BILATERAL LACUNAR INFARCTS, WHICH REQUIRED MEDICATION AND PROLONGED HOSPITALIZATION. CT SHOWED MILD SWELLING AND LOSS OF SULCI IN BILATERAL OCCIPITAL LOBES DUE TO POSSIBLE SUBTLE CONTRAST LEAKAGE, NEURO TOXICITY OR RARE MICRO EMBOLI AND THEREFORE MEDROL DOSE PACK WAS STARTED. LATER IMAGING CONFIRMED INFARCTS. ON (B)(6) 2023 (POD 1), MRS WAS 3. ON (B)(6) 2023 (POD 3), THE VISUAL SYMPTOMS WERE SIGNIFICANTLY IMPROVED. ON (B)(6) 2023 (POD 6), PATIENT WAS DISCHARGED TO HOME WITH FOLLOW-UP SCHEDULED AT STROKE CLINIC AFTER 3-4 WEEKS OF REHAB WITH MRS OF 2. ON (B)(6) 2024 (POD 37), AT THE 30-DAY FU VISIT, MRS WAS 0. THE SITE ASSESSED AS A MINOR STROKE THAT WAS CAUSAL TO PROCEDURE AND POSSIBLY RELATED WITH WEB. RELATIONSHIP TO STUDY DEVICE: POSSIBLY RELATED TO THE INFARCTS, AS THE INFARCTS WERE IPSILATERAL TO THE TARGET ANEURYSM. RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: CAUSAL. RELATIONSHIP TO STUDY DISEASE: POSSIBLE. RELATIONSHIP TO CONCOMITANT DISEASE: POSSIBLE.

  Patient problems: Stroke/CVA

  MAUDE report 18744675 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE WEB PAS CLINICAL STUDY, THE PATIENT EXPERIENCED ACUTE ONSET OF SIGNIFICANT BLURRED VISION AFTER IMPLANTATION OF THE WEB DEVICE ON (B)(6) 2023. THE PATIENT ENDORSES BEING ABLE TO SEE ONLY SHAPES AND SHADOWS. A CT/CTA OF THE HEAD WAS ORDERED RESULTED WITH NO VESSEL ABNORMALITIES OR CLOTS. CT SHOWS MILD SWELLING AND LOSS OF SULCI IN BILATERAL OCCIPITAL LOBES. CT SHOWS POSSIBLE SUBTLE CONTRAST LEAKAGE, NEURO TOXICITY OR RARE MICRO EMBOLI. THE PATIENT STARTED ON A MEDROL DOSE PACK. THE SAME DAY, THIS ADVERSE EVENT HAS BEEN UPDATED TO A MINOR STROKE WITH ADVERSE EVENT TERM ¿BILATERAL LACUNAR INFARCTS¿. MRS CHANGED FROM 0 AT BASELINE TO 2 AT DISCHARGE ON (B)(6) 2023. THE SITE HAS REPORTED THIS EVENT AS POSSIBLY RELATED TO STUDY DEVICE/ANCILLARY DEVICE/STUDY DISEASE/CONCOMITANT DISEASE AND CAUSAL TO PROCEDURE. REPORTEDLY, TWO WEB DEVICES WERE FIRST ATTEMPTED BUT WERE NOT IMPLANTED DUE TO IMPROPER SIZE SELECTION BY THE PHYSICIAN.

  Patient problems: Blurred Vision; Stroke/CVA

  MAUDE report 18332573 ↗
• MalfunctionDec 11, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  SEE H.10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305438 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY WEB PAS (009-001 AE6), SUBJECT IS A 77-YEAR-OLD MALE WHO CONSENTED TO THE WEB PAS CLINICAL TRIAL ON 23MAR2023. SUBJECT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) 2023 WITH RIGHT HEMIPARESIS AND APHASIA; UNABLE TO AMBULATE OR SPEAK WITH RIGHT SIDED WEAKNESS. UPON ARRIVAL VIA MEDFLIGHT, SYMPTOMS HAD RESOLVED. CTA SHOWS THAT LEFT ACA STENT APPEARS OPEN. MRI DONE ON 07MAY2023 SHOWS MULTIPLE SMALL AREAS OF ACUTE ISCHEMIC INJURY WHICH APPEAR TO PREDOMINANTLY CONFINE TO THE TERRITORY OF THE LEFT ANTERIOR CEREBRAL ARTERY SUGGESTING MULTIFOCAL SMALL INFARCTS. AS OF (B)(6) 2023 THE SUBJECT REMAINED MONITORED IN THE HOSPITAL, WITH MEDICATIONS CONTINUING.

  Patient problems: Ischemia; Myocardial Infarction; Paresis; Speech Disorder

  MAUDE report 16955923 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A WEB PAS CLINICAL STUDY, THE WEB WAS EMBOLIZED IN THE PATIENT SUCCESSFULLY, AND THE PATIENT RECOVERED FROM THE GENERAL ANESTHESIA NEUROLOGICALLY INTACT WITHOUT SIGNIFICANT DEFICIT. THIRTY MINUTES POST-PROCEDURE, THE PATIENT DEVELOPED WEAKNESS IN THE PATIENT¿S RIGHT SIDE AND APHASIA, SO THE PATIENT WAS TAKEN TO THE ANGIOGRAM SUITE TO PERFORM AN EMERGENCY CEREBRAL ANGIOGRAM. THE RESULTS PRESENTED A THROMBUS AT THE ANEURYSM NECK CAUSING A SIGNIFICANT DELAY IN THE FLOW OF THE LEFT ACA A2 SEGMENT THAT WAS TREATED WITH INTRA-ARTERIAL AGGRASTAT INFUSION. SUBSEQUENTLY, A STENT WAS DEPLOYED ACROSS THE ANEURYSM NECK IN THE A2 SEGMENT AT THE DISTAL END OF THE LEFT ACA AND PROXIMALLY IN THE A1 SEGMENT OF THE RIGHT-LEFT ACA. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT AND WAS ADMINISTERED AN IV AGGRASTAT DRIP FOR 12 HOURS. THE PATIENT RECOVERED AND WAS REPORTED TO BE BACK TO THE PATIENT¿S BASELINE. THE EVENT IS ATTRIBUTED TO THE DEVICE AND PROCEDURE. ATTEMPTS WERE MADE TO OBTAIN THE TREATMENT NOTES; HOWEVER, THIS INFORMATION HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16710645 ↗
• InjuryNov 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE USING A WEB DEVICE, THE RIGHT MCA ANEURYSM RUPTURED WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE WEB DEVICE. THE WEB DEVICE WAS REMOVED FROM THE PATIENT AND AN EXTERNAL VENTRICULAR DRAINAGE (EVD) WAS PLACED AND COILS WERE USED TO TREAT THE RUPTURE. REPORTEDLY, THE WEB SIZE WAS APPROPRIATE FOR ANEURYSM. THE PATIENT IS HAVING LEFT SIDED DEFICITS AND HAS PRETTY SIZEABLE TRACT HEMORRHAGE FROM THE EVD IMPLANTED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15722550 ↗
• InjurySep 15, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY DETACHING THE DELIVERY PUSHER FROM THE WEB DURING PLACEMENT IN AN ACOMM ARTERY ANEURYSM. THE PROXIMAL END OF THE WEB DEVICE WAS INDENTED DURING REMOVAL OF THE PUSHER. A GOOSE-NECK SNARE WAS USED TO CORRECT THE WEB INDENTATION. THERE WAS NO PATIENT INJURY, WHO REPORTEDLY WAS DOING WELL POST PROCEDURE AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478777 ↗
• InjuryJun 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, A VIA MICROCATEHTER AND WEB DEVICE WERE ADVANCED INTO POSITION WHEN AN ANGIOGRAPHIC RUN REVEALED EXTRAVASATION. IT WAS NOT KNOWN IF THE WEB OR THE VIA CAUSED THE EXTRAVASATION. HEPARIN WAS REVERSED AND THE NEXT ANGIOGRAPHIC RUN REVEALED NO FURTHER EXTRAVASATION. THE WEB WAS IMPEDING FLOW IN THE PARENT VESSEL. A COMPETITOR'S STENT WAS PLACED IN ORDER TO KEEP THE WEB DEVICE IN THE ANEURYSM. FLOW THROUGH THE STENT SHUT DOWN AND INTEGRILLIN WAS ADMINISTERED, WHICH RESTORED FLOW. POST PROCEDURE, THE PATIENT WAS AWAKE, FOLLOWING COMMANDS AND MOVING THEIR RIGHT AND LEFT LEGS. THERE WAS NO REPORTED SEQUELAE.

  Patient problems: Extravasation

  MAUDE report 12029395 ↗

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.