WEB Aneurysm Embolization System W2-8-4-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429107157), received between Apr 17, 2023 and Dec 17, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJul 20, 2023Migration; Separation Problem; Migration; Separation Problem

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY, ON (B)(6) 2023 A 58-YEAR-OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY ROOM FOLLOWING AN EPISODE CONCERNING FOR POSSIBLE SEIZURE. A CT SCAN OF THE HEAD WAS OBTAINED AND DEMONSTRATED AN UNRUPTURED RIGHT MCA ANEURYSM. A WEB DEVICE WAS DEPLOYED IN THE ANEURYSM WITH PLACEMENT IN BOTH MCA BRANCHES PATENT WITH EXCELLENT COVERAGE OF THE ANEURYSM NECK. TWO DETACHERS WERE USED; HOWEVER, NEITHER CONTROLLER SUCCESSFULLY DETACHED THE WEB DEVICE. THEREFORE, THE MICROCATHETER WAS THEN ADVANCED IN AN ATTEMPT TO MANUALLY DETACH THE DEVICE, WHEN DOING THIS THE ENTIRE DEVICE PULLED DOWN INTO THE MCA BIFURCATION. THE WEB NOW IMPINGED ON THE LOWER BRANCH. THE DECISION WAS MADE TO PROCEED WITH STENTING OF THE BRANCH. THE PATIENT WAS GIVEN A BOLUS DOSE OF CANGRELOR FOLLOWED BY A MAINTENANCE DOSE. A MICROCATHETER WAS THEN USED OVER A MICROWIRE TO SELECT THE TARGETED BRANCH. THE MICROWIRE WAS ABLE TO ADVANCE BUT IT WAS A LITTLE DIFFICULT TO PASS THE MICROCATHETER. ONCE THIS WAS SUCCESSFUL, A WIRE WAS PLACED OUT OF THE OTHER BRANCH. A MICROCATHETER WAS USED WITH A MICROWIRE TO KEEP A WIRE IN THE OTHER BRANCH. THEN THE MICROWIRE WAS EXCHANGED FOR A FLOPPY TRAN

  Patient problems: Aneurysm; Convulsion/Seizure

  MAUDE report 17368473 ↗
• InjuryApr 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED THROUGH THE CLINICAL STUDY WEB PAS. THE PATIENT HAD THE WEB DEVICE IMPLANTED, AND A FEW MINUTES AFTER THE IMPLANT THE PHYSICIAN DID AN IMAGING RUN. THEY NOTICED THAT THE DEVICE HAD ROTATED IN THE ANEURYSM APPROXIMATELY 40 DEGREES. THE DEVICE DID NOT LEAVE THE ANEURYSM/TARGETED IMPLANT LOCATION. IT DIDNT CAUSE PARENT VESSEL STENOSIS, DIDNT CAUSE ANY PATIENT INJURY/AE, AND THERE WERE NO ADDITIONAL/ADJUNCTIVE THERAPIES REQUIRED TO TREAT THE ANEURYSM. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753308 ↗

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.