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

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00842429110850), received between Apr 15, 2022 and May 21, 2026 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Separation Failure

  IT WAS REPORTED THAT A WEB DEVICE DID NOT DETACH AFTER MULTIPLE DETACHMENT ATTEMPTS. THE PHYSICIAN TRIED A NEW DETACHER AND THAT DID NOT WORK EITHER. AFTER MULTIPLE ATTEMPTS, A NEW DEVICE WAS OPENED AND THAT ONE DETACHED WITHOUT PROBLEMS. THE ANEURYSM LOCATION WAS BASILAR APEX. PATIENT IS INTACT. THERE WAS NO INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247487 ↗
• MalfunctionApr 9, 2026Separation Failure

  IT WAS REPORTED THAT THE WEB SL IMPLANT WAS DEPLOYED IN A BASILAR ANEURYSM WITH 90 TAKE OFF FROM THE NECK, AND IT WOULD NOT DETACH. THEY USED A VIA-17 STRAIGHT AND HAD A BMX81 WITH A SOFIA5 FR 125 AS INTERMEDIATE SUPPORT. THEY HAD TO REMOVE DEVICE AND USE A 2ND 5X3 DEVICE TO COMPLETE THE PROCEDURE, AND IT DID DETACH. THE PATIENT HAD A GOOD OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24836806 ↗
• InjuryAug 22, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED TO MICROVENTION THAT THE PHYSICIAN WAS PERFORMING AN EMBOLIZATION OF A PARAOPTHALMIC ANEURYSM WITH A WEB, WHICH IS AN OFF-LABEL USE. REPORTEDLY, PRIOR TO THE DEPLOYMENT OF WEB, THE ANEURYSM RUPTURED WHEN THE PATIENT COUGHED UNDER SEDATION, WHICH REPORTEDLY CAUSED THE SYSTEM OF DELIVERY CATHETERS TO MOVE. THE PHYSICIAN THEN WENT TO DEPLOY THE WEB IN THE ANEURYSM BUT THE WEB REPORTEDLY DID NOT DETACH. THE PHYSICIAN PRESSED THE VIA BACK UP TO THE PROXIMAL END OF THE WEB TO BRACE THE DEVICE. UPON BRACING THE VIA, THE WEB REPORTEDLY DETACHED AND CAME TO REST IN THE PARENT VESSEL. THE PHYSICIAN USED VARIOUS TECHNIQUES INCLUDING A SNARE, STRENTRIVER, AND SUCTION THROUGH A .071 CATHETER TO TRY AND RETRIEVE THE WEB. ALL ATTEMPTS REPORTEDLY FAILED, AND THE PHYSICIAN DECIDED TO END THE PROCEDURE. THE PATIENT PASSED AWAY THE FOLLOWING DAY. THIS DEVICE WAS USED IN THE SAME CASE AS THE VIA CATHETER SUBMITTED UNDER A SEPARATE MDR.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22879985 ↗
• MalfunctionAug 13, 2025Separation Failure; Separation Failure

  NO FURTHER ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800936 ↗
• MalfunctionJul 15, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO DETACH FROM THE PUSHER WIRE DESPITE MULTIPLE ATTEMPTS. THE PHYSICIAN WAS ABLE TO RESHEATH THE DEVICE AND USE A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION PERFORMED. PATIENT OUTCOME AND CONDITION WERE NOT AFFECTED BY THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516436 ↗
• MalfunctionSep 4, 2024Separation Failure; Separation Failure

  AS REPORTED: WEB WOULD NOT DETACH. TOLD BY PHYSICIAN MULTIPLE DETACHERS WERE TRIED. A 6X2 WEB WAS USED AND COMPLETED THE CASE SUCCESSFULLY. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141092 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: RT GROIN ACCESS. A 6FR ACCESS SHEATH WAS PLACED. A 5FR SOFIA 115CM WAS ADVANCED THROUGH THE ACCESS SHEATH. A VIA 17 WAS ADVANCED INTO THE RT PCOMM ANEURYSM. THE 6-2 WEB WAS THEN INITIALLY PLACED INTO THE ANEURYSM BUT THE POSITION OF THE WEB WAS UNSATISFACTORY AND WAS REMOVED. A 5-3 WEB WAS THEN SELECTED AND ADVANCED. A CONTRAST RUN WAS DONE JUST PRIOR TO THE 5-3 WEB ADVANCEMENT INTO ANEURYSM WHICH DEMONSTRATED EXTRAVASATION OF CONTRAST. THE 5-3 WEB WAS QUICKLY DEPLOYED. THE PHYSICIAN FELT NO NEED TO INTERVENE. THE 5X3 WEB WAS PLACED AND IT LOOKED IN GOOD POSITION; THE PHYSICIAN ENDED THE PROCEDURE. PATIENT IS STABLE AND EXTUBATED. THIS REPORT CAPTURES THE EXTRAVASATION OF CONTRAST.

  Patient problems: Extravasation

  MAUDE report 20057507 ↗
• InjuryJun 4, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THIS WAS A TALL ACOMM ANEURYSM MEASURING 4.1 W X 5 H (HE WASN¿T MEASURING TO THE DOME) THE PLAN WAS JUST TO COVER THE NECK. DECIDED TO USE A 5X3 SL. WHEN TESTING THE WDC TO THE WIRE IT RESPONDED WITH A GREEN THEN RED LIGHT. THAT HAPPENED A COUPLE OF TIMES. THE TECH WIPED THE WEB PUSHER WIRE WITH A DRY CLOTH, THEN TRIED AGAIN. THIS RESULTED IN A GREEN LIGHT. PROCEEDED TO PLACE THE WEB AND WHEN THE PHYSICIAN WAS READY TO DETACH, HE PUSHED THE WDC BUTTON AND GOT A RED/GREEN LIGHT. HE PRESSED A FEW MORE TIMES ARE GOT ONE GREEN, THEN TWO MORE RED/GREEN LIGHTS. THE WEB WAS NOT DETACHED SO HE PROCEEDED TO USE THE BRACING TECHNIQUE TO FORCE THE TETHERS TO DETACH. THAT WORKED, BUT UPON FURTHER INVESTIGATION, HE REALIZED THAT THE WEB WAS PULLED PARTIALLY OUT THE ANEURYSM AND BLOCKING ONE OF THE A2 VESSELS. HE DECIDED TO LVIS STENT THE WEB TO PUSH IT BACK TOWARD THE ANEURYSM AND RE-OPEN THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 19464057 ↗
• MalfunctionMay 6, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT A WEB DEVICE WAS SUCCESSFULLY PLACED IN THE ANEURYSM AND DELIVERED A SUCCESSFUL DETACHMENT CHARGE, BUT THE DEVICE DID NOT DETACH. MULTIPLE ATTEMPTS WERE PERFORMED TO DETACH THE WEB BUT WOULD NOT DETACH FROM THE WIRE. THE DEVICE WAS REMOVED, AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE AND WAS DISCHARGED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19245910 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY WEB PAS: DURING PROCEDURE ON (B)(6) 2023, WEB DEVICE WAS NOT IMPLANTED AS THE PHYSICIAN WAS NOT HAPPY WITH PLACEMENT OF DEVICE AFTER SEVERAL ATTEMPTS, SO DEVICE WAS NOT DETACHED. THE CLINICAL SITE DENIED ANY TE AND THE PROCEDURE REPORT CONFIRMS THE DEVICE NOT BEING IMPLANTED WAS RELATED TO ANEURYSM ANATOMY/ORIENTATION (NOT MALFUNCTION). INCIDENT OF A TRANSIENT ISCHEMIC ATTACK DID NOT REQUIRE INTERVENTION BESIDES HOSPITALIZATION. PATIENT NOTED TO BE RECOVERED/ ISSUE RESOLVED ON (B)(6) 2023. EVENT TERM : TRANSIENT ISCHEMIC ATTACK. EVENT START DATE : 16-MAR-2023. WAS THIS A SERIOUS AE? : YES. HOSPITALIZATION PROLONGED : X. RELATIONSHIP TO STUDY DEVICE : POSSIBLE. RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE : CAUSAL. RELATIONSHIP TO USE OF ANCILLARY DEVICE : POSSIBLE. RELATIONSHIP TO STUDY DISEASE : NOT RELATED. RELATIONSHIP TO CONCOMITANT DISEASE : NOT RELATED. AE OUTCOME : RECOVERED/RESOLVED. RECOVERED/RESOLVED: DATE OF RESOLUTION : 17-MAR-2023. AS THE REPORTED TRANSIENT ISCHEMIC ATTACK IS INDICATED AS POSSIBLY RELATED TO THE STUDY DEVICE, WEB, INCIDENT IS BEING REPORTED.

  Patient problems: Transient Ischemic Attack

  MAUDE report 19122322 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED, PLEASE SEE H6 & H10.

  Patient problems: Speech Disorder; Transient Ischemic Attack

  MAUDE report 18785323 ↗
• InjurySep 13, 2023Adverse 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 THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS AFTER TREATMENT WITH A WEB FOR AN UNRUPTURED LICA TERMINUS ANEURYSM 6X4MM. POST PROCEDURE, THE SUBJECT DEVELOPED RIGHT UPPER EXTREMITY WEAKNESS AND RIGHT SIDED NUMBNESS. A CT HEAD SHOWED A COMBINATION OF A SMALL AMOUNT OF SUBARACHNOID HEMORRHAGE AND EXTRAVASATED CONTRAST IN THE LEFT SUPRATENTORIAL COMPARTMENT. A REPEAT CT HEAD ON ONE DAY POST PROCEDURE SHOWED RESOLUTION OF THE PREVIOUSLY NOTED SUBARACHNOID HEMORRHAGE. THERE WAS NO EVIDENCE OF THROMBOEMBOLIC COMPLICATIONS OR SIGNIFICANT FLOW RESTRICTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FIVE DAYS POST OP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia; Muscle Weakness/Atrophy

  MAUDE report 17741458 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) (COPD) PATIENT UNDERWENT A PROCEDURE TO TREAT A SMALL MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH A MICROVENTION (MV) WEB SL 5 X 3 STENT AND SUFFERED A RUPTURED MCA ANEURYSM, REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, A MV WEB SL 4 X 3 WAS DEPLOYED AND REMOVED, AS IT WAS TOO SMALL FOR THE ANEURYSM. THEREAFTER, A WEB SL 5 X 3 WAS DEPLOYED AND WOULD NOT ENTER THE MV VIA 17 CATHETER. A SECOND WEB SL 5 X 3 STENT WAS DEPLOYED AND THE SMALL MCA ANEURYSM RUPTURED. THE WEB SL 5 X 3 WAS REMOVED, AND 2 UNKNOWN COILS WERE USED TO TREAT THE ANEURYSM. A SCEPTER 4 X10 BALLOON CATHETER WAS USED AFTER THE UNKNOWN COILS WERE DEPLOYED. GENERAL ANESTHESIA WAS NOT ADMINISTERED TO THE PATIENT. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 14139442 ↗
• InjuryApr 15, 2022Break; Entrapment of Device; Fracture; Break; Entrapment of Device; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTERIO VENOUS MALFORMATION (AVM) EMBOLIZATION PROCEDURE WHERE BOTH SCEPTER BALLOON AND CATHETER SEPARATION OCCURRED. DURING THE PROCEDURE, 25% PHIL¿ WAS INJECTED USING SCEPTER MINI FOR EMBOLIZATION OF AVM. AFTER EMBOLIZATION, IT WAS DIFFICULT TO REMOVE THE MV SCEPTER MINI BALLOON MICROCATHETER BECAUSE THE BALLOON WAS TRAPPED BY THE PHIL¿ CAST. THE SCEPTER MINI WAS FRACTURED, AND THE DISTAL PART REMAINED WITHIN THE PATIENT. THE DISTAL PART OF THE CATHETER WAS REMOVED WITH NIDUS BY SURGERY. THE VERTEBRAL ARTERY WAS OCCLUDED AFTER EMBOLIZATION AND NO SEVERE INJURY OCCURRED. THE PATIENT IS REPORTED TO BE UNDER VENTILATION. HOWEVER, THE REASON OR THE RELATIONSHIP TO THE PROCEDURE IS UNKNOWN.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 14124315 ↗

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.