WEB W5-4.5-2-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00842429110799), received between Jul 29, 2022 and Jun 9, 2026 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Difficult or Delayed Separation

  IT WAS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: A DEVICE DEFICIENCY HAS BEEN REPORTED FOR SUBJECT: CAR-33-003 AT SITE: 33 PLEASE REVIEW THE FOLLOWING INFORMATION: EVENT NUMBER: 1 DATE OF DEVICE DEFICIENCY: 14-APR-2026 PROCEDURE PRIMARY TREATMENT DEVICE: WEB (WEB) TYPE OF DEVICE DEFICIENCY (WEB): DIFFICULT/DELAYED/STICKY DETACHMENT (DIFFICULT/DELAYED/STICKY DETACHMENT) DEVICE DEFICIENCY DESCRIPTION: STICKY DETACHMENT WEB DEVICE MODEL: SL MODEL (SL MODEL) WEB SL MODEL: W5-4.5-2 (W5-4.5-2) LOT# OF DEVICE THAT EXPERIENCED A DEVICE DEFICIENCY: 0000598356 DID SUBJECT REQUIRE OTHER TREATMENT/INTERVENTION AS A RESULT OF THE MALFUNCTION/DEFICIENCY THAT IS NOT ASSOCIATED WITH ANY ADVERSE EVENT? N (NO) COULD THIS DEVICE DEFICIENCY HAVE LED TO A SERIOUS ADVERSE DEVICE EFFECT (SADE): 1. IF EITHER SUITABLE ACTION HAD NOT BEEN TAKEN, 2. IF INTERVENTION HAD NOT BEEN MADE, OR 3. IF CIRCUMSTANCES HAD BEEN LESS FORTUNATE: N (NO) THE PROCEDURE WAS COMPLETED. THE PATIENT OUTCOME IS ALIVE AND WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451859 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE COMPLEX ANEURYSM REGISTRY (CAR): A PATIENT WITH A HISTORY OF HYPERTENSION WHO PRESENTED WITH A SEVERE HEADACHE ON THE MORNING OF ADMISSION AND WAS FOUND TO HAVE A DIFFUSE SUBARACHNOID HEMORRHAGE. ON ARRIVAL, PATIENT WAS NOTED TO BE DROWSY, AND REPEAT IMAGING DEMONSTRATED HYDROCEPHALUS. CTA REVEALED A RIGHT MCA ANEURYSM. THE PATIENT UNDERWENT SUCCESSFUL EVD PLACEMENT AND ANEURYSM EMBOLIZATION. DUE TO THE WIDE-NECKED NATURE OF THE RIGHT MCA ANEURYSM, WEB EMBOLIZATION WITH STENT ASSISTANCE WAS PERFORMED. HOWEVER, ON ROUTINE FOLLOW-UP ANGIOGRAPHY, THE ANEURYSM REMAINED SIGNIFICANTLY PATENT, AND A SECOND EMBOLIZATION ATTEMPT WITH COILS WAS PERFORMED TWELVE DAYS POST-INDEX PROCEDURE. THE PATIENT DID WELL POST-OP. ON THE THIRTEENTH DAY POST-INDEX PROCEDURE, THE PATIENT DEVELOPED ACUTE WEAKNESS IN THE LEFT UPPER EXTREMITY ALONG WITH A DECREASED LEVEL OF CONSCIOUSNESS. A NON-CONTRAST CT HEAD (CTH) WAS NEGATIVE FOR NEW HEMORRHAGE, AND CLINICAL VASOSPASM WAS CONSIDERED IN THE DIFFERENTIAL DIAGNOSIS. A CEREBRAL ANGIOGRAM WITH INTRA-ARTERIAL TREATMENT FOR VASOSPASM WAS RECOMMENDED. PREOPERATIVE DIAGNOSIS: SYMPTOMATIC VASOSPASM AFTER ANEURYSMAL SUBARACHNOID HEMORRHAGE. PO

  Patient problems: Aneurysm; Muscle Weakness/Atrophy

  MAUDE report 24955822 ↗
• MalfunctionAug 8, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE WEB WAS POSITIONED IDEALLY, HOWEVER WOULD NOT DETACH. SEVERAL ATTEMPTS WERE TRIED INCLUDING OPENING A NEW DETACHMENT CONTROLLER. THIS WEB WAS SAFELY REMOVED AND A NEW DEVICE WAS IMPLANTED AND DETACHED ON FIRST ATTEMPT. IT WAS ATTEMPTED TO DETACH THIS DEVICE ON THE BACK TABLE AFTER THE CASE, AND IT STILL DID NOT DETACH. THE PHYSICIAN THEN MANUALLY PULLED THE DEVICE OFF OF THE PUSHER. THE WEB AND WIRE ARE ALL BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755298 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H11.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21862552 ↗
• InjuryOct 14, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AS REPORTED DURING AN RMCA ANEURYSM TREATMENT, THE WEB WAS DETACHED AND MIGRATED BELOW THE ANEURYSM OBSTRUCTING THE SUPERIOR M2 ARTERY. THE FLOW WAS VISIBLY SLOW. THE PATIENT LEFT INTUBATED AND ON DUAL ANTIPLATELET THERAPY. THE PATIENT IS DOING WELL AND IS ABLE TO AMBULATE WITHOUT ASSISTANCE. LANGUAGE IS SEVERELY IMPAIRED, BUT THE STROKE ON CT WAS ACTUALLY PRETTY SMALL. THE PATIENT WILL RECOVER OVER TIME.

  Patient problems: Speech Disorder

  MAUDE report 20447497 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION WAS RECEIVED, PLEASE SEE H6 & H11.

  Patient problems: Aneurysm

  MAUDE report 20304806 ↗
• MalfunctionJul 10, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED THROUGH THE CAR CLINICAL STUDY: NO DETACHMENT OCCURRED UPON DETACHMENT ACTIVATION. IT WAS EASILY RESOLVED BY ADVANCING THE MICROCATHETER TO THE PROXIMAL MARKER OF THE WEB DEVICE AND SLOWLY PUSHING BACK ON THE PUSHER WIRE. PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713694 ↗
• MalfunctionJul 3, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19663055 ↗
• InjuryJun 14, 2024Difficult or Delayed Positioning; Unintended Movement; Difficult or Delayed Separation; Difficult or Delayed Positioning; Unintended Movement; Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION RECEIVED. ¿ PLEASE SEE H6 AND H11.

  Patient problems: Insufficient Information

  MAUDE report 19541941 ↗
• InjuryMay 3, 2024Migration or Expulsion of Device; Separation Failure; Detachment of Device or Device Component; Migration or Expulsion of Device; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN INTRASACCULAR FLOW DISRUPTION DEVICE WAS DELIVERED INTO AN ACOM ANEURYSM VIA THE LEFT ICA AND LEFT A1 SEGMENT. THE IMPLANT WOULD NOT DETACH WITH A DETACHMENT CONTROLLER. DURING ATTEMPTS TO DETACH THE IMPLANT, THE DEVICE MIGRATED INFERIOR TO THE ANEURYSM AND BECOME LODGED INTO THE ACOM BIFURCATION, SLOWING FLOW AND EVENTUALLY SHUTTING DOWN THE LEFT A2 VESSEL. THE PATIENT WAS REPORTED TO BE STABLE AND HAD NOT EXPERIENCED ANY SEQUELAE AT THE TIME. THERE WAS REPORTEDLY NO INTERVENTION PERFORMED OR PLANNED. THE VESSEL REPORTEDLY RECEIVED COLLATERAL BLOOD FLOW.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19244138 ↗
• MalfunctionMay 2, 2024Separation Failure; Separation Problem; Separation Failure; Separation Problem

  IT WAS REPORTED THAT DURING A WEB EMBOLIZATION PROCEDURE, THE WEB FAILED TO DETACH. ANOTHER WEB WAS USED AND THE PROCEDURE WAS COMPLETED WITH MINIMAL DELAY. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO NEGATIVE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235556 ↗
• MalfunctionApr 22, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE WEB DEVICE DID NOT DETACH. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO DETACH THE DEVICE AND WITH DIFFERENT DETACHERS. HOWEVER, THE WEB DEVICE DETACHMENT WAS UNSUCCESSFUL. THEREFORE, PHYSICIAN RE-CAPTURED THE DEVICE AND REMOVED FROM THE PATIENT. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154266 ↗
• MalfunctionApr 16, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED THROUGH THE CLINICAL STUDY COMPLEX ANEURYSM REGISTRY (CAR): DURING INTRACRANIAL ANEURYSM TREATMENT OF AN UNRUPTURED SIDEWALL ANEURYSM USING THE WEB DEVICE FOR THE CAR REGISTRY ON (B)(6) 2024 THERE WAS SLIGHT STICKY TETHER OF WEB SL W5-4.5-2. THERE WAS NO OTHER TREATMENT/INTERVENTION NEEDED AS A RESULT OF THE MALFUNCTION. THE WEB WAS USED AND REMAINS IMPLANTED. A VIA 17 CATHETER WAS USED. PER THE CLINICAL SITE THERE WAS NO IMPACT TO THE PATIENT AND THE DEFICIENCY DID NOT LEAD TO AN ADE. DSA IMAGING DONE (B)(6) 2024 SHOWS 100 PERCENT ANEURYSM ANGIOGRAPHIC OCCLUSION (B)(6) OCCLUSION CLASSIFICATION (RROC): CLASS 3. PARENT ARTERY PATENCY: WIDELY PATENT. WEB OCCLUSION SCALE (WOS): WOS B. INDEX ANEURYSM RECURRENCE? NO. REDACTED PROCEDURE NOTE INDICATED: PROCEDURE(S): 1. TRANSCATHETER EMBOLIZATION, CNS: SUPERIOR HYPOPHYSEAL RIGHT ICA ANEURYSM ((B)(6)) 2. TRANSCATHETER THERAPY, EMBOLIZATION, RADIOLOGICAL SUPERVISION AND INTERPRETATION ((B)(6)) 3. SELECTIVE CATHETER PLACEMENT, RIGHT INTERNAL CAROTID ARTERY, WITH ANGIOGRAPHY OF THE INTRACRANIAL CAROTID CIRCULATION ((B)(6)) 4. ANGIOGRAPHY THROUGH EXISTING CATHETER FOR FOLLOW-UP STUDY FOR TRANSCATHETER THERAPY, EMBOLIZATION ((B)(6))

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122119 ↗
• MalfunctionMar 26, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING A WEB EMBOLIZATION PROCEDURE TO TREAT AN MCA BIFURCATION ANEURYSM, THE WEB DISPLAYED A GREEN LIGHT, AND IT DID NOT DETACH. ALL TROUBLESHOOTING PROTOCOLS WERE ATTEMPTED, BUT THE WEB STILL WOULD NOT DETACH. THE WEB WAS RE-SHEATHED AND REMOVED, AND A STENT COIL EMBOLIZATION WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984027 ↗
• MalfunctionAug 9, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION WAS RECEIVED. PLEASE SEE D10, H6 AND H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495416 ↗
• InjuryMar 28, 2023Separation Failure; Device Dislodged or Dislocated; Separation Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A WEB DEVICE WAS IMPLANTED IN A RIGHT ICA ANEURYSM BUT WOULD NOT DETACH AFTER THE USE OF THE DETACHMENT CONTROLLER. THE MICROCATHETER WAS USED TO PUSH THE IMPLANT OFF OF THE DELIVERY PUSHER, BUT THE IMPLANT DISLODGED FROM THE ANEURYSM. A STENT WAS USED TO TACK THE PROTRUDING WEB AGAINST THE ARTERIAL WALL. THE PATIENT WAS REPORTED TO HAVE WOKE UP FROM ANESTHESIA NEUROLOGICALLY INTACT. THE DEVICE WAS USED IN THE SAME CASE AS THE DEVICE REPORTED IN 2032493-2023-00635.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632976 ↗
• InjuryFeb 2, 2023Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

  IT WAS REPORTED THAT WHEN DETACHING THE WEB DEVICE DURING A RUPTURED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM CASE, A DELAYED DETACHMENT FROM THE WIRE CAUSED THE DEVICE TO MOVE BACK AND IT COVERED THE INFERIOR MCA BRANCH. THE PHYSICIAN UTILIZED INTEGRILIN BOLUS AND BRILINTA, WAITED 5 MINUTES AND IT APPEARED THE OCCLUSION WAS AT M2 SEGMENT. THE PHYSICIAN IMPLANTED A LVIS JR. STENT TO SUPPORT THE WEB. THE M2 SEGMENT REMINES OCCLUDED. THE PATIENT WAS DISCHARGED 3 DAYS POST PROCEDURE AND IS NEUROLOGICALLY INTACT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16286885 ↗
• InjuryAug 29, 2022Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

  IT WAS REPORTED THAT A WEB DEVICE HAD TROUBLE DETACHING DURING PLACEMENT. MULTIPLE DETACHMENT DEVICES WERE USED AND THE WEB EVENTUALLY DETACHED. THE WEB WAS NOTICED TO BE ENCROACHING ON THE PARENT VESSEL, SO A STENT WAS PLACED TO HOLD THE WEB IN PLACE. POST-PLACEMENT OF THE STENT, CLOT WAS NOTICED. THE PATIENT WAS REPORTED TO BE "DOING WELL" TWO DAYS AFTER THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15317447 ↗
• InjuryJul 29, 2022Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

  IT WAS REPORTED THAT A WEB DEVICE WAS DEPLOYED IN AN ACOM ANEURYSM BUT WOULD NOT DETACH AFTER THREE DETACHMENT ATTEMPTS WITH A DETACHMENT CONTROLLER. THE MICROCATHETER WAS MOVED FORWARD, RESULTING IN THE WEB'S DETACHMENT, BUT ALSO RESULTING IN THE WEB SHIFTING POSITION WITHIN THE ANEURYSM AND IMPINGING UPON THE PARENT VESSEL. WHILE NAVIGATING PAST THE ANEURYSM WITH A WIRE IN ORDER TO PLACE A STENT, THE WEB DISLODGED AND FLOATED DOWNSTREAM INTO THE ACA. A SNARE DEVICE WAS USED TO RETRIEVE IT, BUT WAS ULTIMATELY UNSUCCESSFUL AND THE WEB WAS PUSHED FURTHER TO A DISTAL ACA BRANCH AT A BIFURCATION. A STENT WAS PLACED TO RETAIN PATENCY OF THE DISTAL ACA VESSELS AND TO HOLD THE WEB IN PLACE. FOLLOW UP IMAGING SHOWED ALL BRANCHES STILL FILLING AT TIME OF PROCEDURE END. THE ACOM ANEURYSM WAS LEFT UNTREATED AT THIS TIME. PATIENT WAS STARTED ON AN AGGRASTAT DRIP FOR 12 HOURS WITH REPEAT DIAGNOSTIC ANGIOGRAM TO FOLLOW IN THE MORNING. THE ANGIOGRAM REVEALED THAT THE VESSEL ARE CURRENTLY WIDE OPEN. THE PATIENT PRESENTS WITH EXPRESSIVE APHASIA THAT THE PHYSICIAN BELIEVES IS FROM MANIPULATIONS FROM TRYING REMOVE THE WEB.

  Patient problems: Brain Injury

  MAUDE report 15131951 ↗

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.