WEB Aneurysm Embolization SystemRecalls & reported problems across all models

We found 15 models of WEB Aneurysm Embolization System by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2020 and Jul 1, 2026 — classified as 2 deaths, 34 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WEB Aneurysm Embolization System problems

WEB Aneurysm Embolization System models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WEB Aneurysm Embolization System W2-8-3-MVI-3

  Intrasaccular Flow Disruption Device
  14 reports
• WEB Aneurysm Embolization System W2-9-4-MVI-3

  Intrasaccular Flow Disruption Device
  1 death7 reports
• WEB Aneurysm Embolization System W2-8-4-MVI-3

  Intrasaccular Flow Disruption Device
  4 reports
• WEB Aneurysm Embolization System W2-9-5-MVI-3

  Intrasaccular Flow Disruption Device
  4 reports
• WEB Aneurysm Embolization System W2-10-5-MVI-3

  Intrasaccular Flow Disruption Device
  3 reports
• WEB Aneurysm Embolization System W4-5-3-MVI-3

  Intrasaccular Flow Disruption Device
  2 reports
• WEB Aneurysm Embolization System W4-7-4-MVI-3

  Intrasaccular Flow Disruption Device
  2 reports
• WEB Aneurysm Embolization System W2-8-5-MVI-3

  Intrasaccular Flow Disruption Device
  2 reports
• WEB Aneurysm Embolization System W2-11-9-MVI-3

  Intrasaccular Flow Disruption Device
  2 reports
• WEB Aneurysm Embolization System W4-6-3-MVI-3

  Intrasaccular Flow Disruption Device
  1 death1 report
• WEB Aneurysm Embolization System W4-7-3-MVI-3

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W2-8-6-MVI-3

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W2-9-7-MVI-3

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W2-10-6-MVI-3

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W2-11-7-MVI-3

  Intrasaccular Flow Disruption Device
  1 report

Recent WEB Aneurysm Embolization System adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE WEB PAS STUDY: ANEURYSM RECURRENCE WITH RETREATMENT. THIS EVENT IS RELATED TO THE DEVICE. STUDY: (B)(6). SUBJECT: (B)(6). EVENT #: 2 EVENT TERM: ANEURYSM RECURRENCE WITH RETREATMENT. EVENT START DATE: 16-DEC-2025. WAS THIS A SERIOUS AE? YES. ADDITIONAL INFORMATION: NOTIFICATION DATE: 14JAN2026. AN UPDATE REGARDING WEB-35-003. THIS PARTICIPANT TARGET ANEURYSM WAS RETREATED (EMBOLIZATION PERFORMED) ON (B)(6) 2026 SINCE THE 12M FU IMAGING ON (B)(6) 2025 SHOULD ANEURYSM RECURRENCE AND A TE OF WEB DEVICE COMPRESSION.

  Patient problems: Aneurysm

  MAUDE report 24242456 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ANEURYSM RUPTURED WHILE DEPLOYING THE WEB. AN EVD WAS PLACED. THE PATIENT WAS EXTUBATED AND FOLLOWING COMMANDS. THE PATIENT IS SLOWLY IMPROVING.

  Patient problems: Ruptured Aneurysm

  MAUDE report 24090174 ↗
• InjuryDec 17, 2025Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A RIGHT MCA WIDE NECK ANEURYSM, THE WEB WAS PUSHED INTO THE DOME BEFORE IT EXPANDED, WHICH CAUSED A RUPTURE. AN ATTEMPT WAS MADE TO DEPLOY THE WEB USING THE FIRST DETACHER, BUT THERE WAS NO GREEN OR RED LIGHT; IT WAS COMPLETELY NOT RESPONDING. THE DOCTOR THEN CLEANED THE PROXIMAL END OF WEB PROCEEDED TO TRY AGAIN, BUT IT WAS SAME OUTCOME. ANOTHER DETACHER WAS USED, BUT IT HAD THE SAME RESULT. AFTER THE PROCEDURE, THE PATIENT WAS SENT TO PERFORM A CT SCAN TO CHECK FOR BLEEDING. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CASE WAS COMPLETED USING COMPETITOR COILS, COILING OFF THE ANEURYSM. THE RUPTURE WAS TREATED WITH USING STANDARD COILS. AFTER THE PROCEDURE, OUTSIDE THE PATIENT¿S BODY, THE WEB WAS TESTED AGAIN, AND IT STILL WOULD NOT DETACH. THE ONLY PATIENT INFORMATION OBTAINED FROM THE PHYSICIAN THE FOLLOWING DAY INDICATED THAT THE PATIENT WAS IN STABLE CONDITION; HOWEVER, THEY HAD SUFFERED FROM A SEVERE HEADACHE.

  Patient problems: Headache; Ruptured Aneurysm

  MAUDE report 23834102 ↗
• 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 ↗
• InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE WEB INTRASACCULAR FLOW DISRUPTION DEVICE WAS USED FOR A DISTAL ICA ANEURYSM EMBOLIZATION. AFTER THE DEVICE WAS DETACHED IN THE ANEURYSM, IT WAS NOTED THAT THE SELECTED SIZE WAS TOO SMALL FOR THE ANEURYSM AND THE DEVICE ROTATED SLIGHTLY WITHIN THE ANEURYSM; HOWEVER, IT REMAINED FULLY CONTAINED WITHING THE ANEURYSM SACK. A SHORT ATTEMPT WAS MADE TO COAX THE WEB INTO A MORE COAXIAL POSITION WITHIN THE ANEURYSM, BUT IT REMAINED OUT OF POSITION. THE DECISION WAS THEN MADE TO USE HYDROGEL COILS AND PLACE THEM PROXIMALLY TO THE WEB. ONCE THE COILS WERE INTRODUCED, THE WEB ORIENTATION WAS CORRECTED AND THE ANEURYSM WAS SUCCESSFULLY TREATED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589375 ↗
• InjuryNov 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS OBTAINED FROM THE PHYSICIAN STATING THAT THE PATIENT HAS BEEN PLACED ON COMFORT CARE.

  Patient problems: Status Epilepticus; Swelling/ Edema

  MAUDE report 23564224 ↗
• 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 ↗
• MalfunctionAug 18, 2025Separation Failure; Separation Failure

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835300 ↗
• 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 ↗
• MalfunctionJun 4, 2025Separation Failure; Separation Failure

  IT WAS REPORTED: DEVICE WAS NOT ABLE TO DETACH FROM DELIVERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A DIFFERENT SIZE WEB DEVICE THOUGHT TO BE 7X5. THERE WAS NO PATIENT IMPACT, INJURY OR INTERVENTION. THE PATIENT IS DOING WELL. THE DEVICE WAS DISCARDED. NO OTHER INCIDENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145655 ↗
• 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 ↗
• 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 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE WEB PAS STUDY: THE REPORTED ANEURYSM REOCCURRENCE IS INDICATED TO HAVE A PROBABLE RELATION TO THE STUDY DEVICE, WEB. THE AE IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 21722263 ↗

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