WEB W5-6-3-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00842429110881), received between Sep 28, 2022 and May 20, 2025 — classified as 1 death, 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: INDEX ANEURYSM RECURRENCE. "PARTICIPANT WILL BE RETREATED DUE TO ANEURYSM RECURRENCE NOTED AT THE 12M FU VISIT." ¿STUDY PARTICIPANT ENROLLED INTO THE WEB STUDY AFTER PRESENTING WITH A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. UPON 1 YEAR FOLLOW-UP DSA A 2.8MM X 2.4MM ANEURYSM RECURRENCE AT THE NECK OF THE ANEURYSM WAS NOTED AND SCORED AS A RAYMOND RAY 2. PARTICIPANT HAS NO SYMPTOMS OF ANEURYSM RECURRENCE. RE-TREATMENT ENDOVASCULAR PROCEDURE TO BE SCHEDULED FOR A FUTURE DAY.¿ THE EVENT HAS BEEN ADJUDICATED AS POSSIBLY RELATED TO THE STUDY DEVICE AND INDEX PROCEDURE, AND PROBABLY RELATED TO THE STUDY DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055701 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE WEB SL DEVICE WAS USED TO TREAT A MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM. THE CASE WENT EXTREMELY WELL AND DONE IN LESS THAN AN HOUR. FEMORAL ACCESS WAS NORMAL AND NAVIGATION TO THE LEFT ICA AND MCA WAS NO ISSUE. THE WEB WAS DEPLOYED WITH NO ISSUE. THE AVERAGE WIDTH WAS 4.0 AND HEIGHT WAS 4.7. THE PATIENT WAS KEPT ON DAPT POST PROCEDURE EVEN THOUGH IT WAS NOT RECOMMENDED BY THE PROCTOR BECAUSE THERE WAS NO PARENT VESSEL PROTRUSION. IN A FOLLOW-UP WITH THE PHYSICIAN, IT WAS REPORTED THAT THE PATIENT PRESENTED ONE WEEK LATER WITH A TEMPORAL LOBE HEMORRHAGE. THE REASON COULD NOT BE PIN POINTED. IT IS UNKNOWN IF ANY TREATMENT WAS DONE TO TREAT THE HEMORRHAGE. THE PATIENT IS DOING FINE WITH SLIGHT APHASIA THAT THE PHYSICIAN EXPECTS TO SUBSIDE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Speech Disorder

  MAUDE report 21704342 ↗
• MalfunctionMar 25, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION RECEIVED, PLEASE SEE H6 & H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684864 ↗
• MalfunctionMar 24, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT TWO WEB DEVICES WERE USED DURING AN ANEURYSM EMBOLIZATION CASE. THE WEB WAS UNABLE TO DETACH FROM THE DELIVERY PUSHER WITH THE USE OF MULTIPLE DETACHMENT DEVICES. THE WEB WAS WITHDRAWN AND REMOVED FROM THE PATIENT. A SECOND WEB DEVICE WAS PLACED AND WAS UNABLE TO DETACH. UPON REMOVAL AND RETRACTION OF THE WEB, THE DEVICE DETACHED WITHIN THE MICROCATHETER. THE WEB AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH A THIRD WEB DEVICE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THIS IS REPORT 1 OF 2 AND ADDRESSES THE FIRST WEB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684856 ↗
• InjuryMar 4, 2025Collapse; Device Slipped; Adverse Event Without Identified Device or Use Problem; Collapse; Device Slipped; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WEB PAS CLINICAL STUDY, A RAYMOND-ROY CLASS 2B RECURRENCE OF THE PREVIOUSLY EMBOLIZED RUPTURED ANEURYSM OCCURRED. THE DEPLOYED WEB DEVICE COLLAPSED AND WAS PUSHED FURTHER INTO THE DOME OF THE ANEURYSM. THE PATIENT IS PLANNING TO RECEIVE RETREATMENT BY UTILIZING ADJUNCTIVE IMPLANT WITH A FLOW-DIVERTER. THE AE IS ONGOING. THE RELATIONSHIP TO THE DEVICE IS CAUSAL. THE RELATIONSHIP TO THE PROCEDURE IS POSSIBLE. ADDITIONAL INFORMATION REGARDING THE PATIENT'S RETREATMENT STATUS WAS REQUESTED FROM THE REPORTER. NO INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 21521173 ↗
• MalfunctionOct 13, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE WEB EMBOLIZATION DEVICE WAS USED IN AN UNSPECIFIED PROCEDURE. THE WEB DEVICE WAS TESTED WITH THE WDC CONTROLLER PER THE IFU, AND A GREEN LIGHT WAS DISPLAYED INDICATING THE CIRCUIT WAS GOOD. UPON COMPLETION OF TESTING AND DEVICE PREP, THE WEB DEVICE WAS ADVANCED AND PLACED IN THE ANEURYSM. THE WDC CONTROLLER WAS CONNECTED TO THE END OF WEB DEVICE TO INITIATE THE DETACHMENT SEQUENCE, AND NO LIGHTS WERE VISIBLE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE AND REATTACH THE WDC CONTROLLER THE WEB PUSHER WIRE WITH NEITHER LIGHT WAS VISIBLE. A SECOND WDC CONTROLLER WAS OPENED AND ATTACHED TO WEB DEVICE AND STILL NO LIGHT WAS VISIBLE. THE WEB DEVICE WAS RESHEATHED AND REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH ANOTHER WEB DEVICE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436510 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H.11.

  Patient problems: Aneurysm

  MAUDE report 20412575 ↗
• InjuryMay 23, 2024Device Dislodged or Dislocated; Material Protrusion/Extrusion; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN EMERGENT TREATMENT OF A RUPTURED BASILAR TIP ANEURYSM FOR A PATIENT, ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY WITH A GUIDE CATHETER AND 5FR CATHETER FOR INTERMEDIATE SUPPORT. INITIAL 2D AND 3D ANGIOGRAPHIC IMAGES WERE OBTAINED. ANEURYSM MEASUREMENTS DETERMINED THE AVERAGE WIDTH WAS 4.7MM, WITH A HEIGHT OF 3.5-3.7MM IN VARIOUS PROJECTIONS. THE IDEAL WEB SIZE FOR EFFECTIVE TREATMENT OF THIS ANEURYSM, ACCORDING TO OUR SIZING CHART, IS A 6X2 WEB SL. THIS SIZE IS BACKORDERED AND CURRENTLY UNAVAILABLE, AD THE USER FACILITY DID NOT HAVE THAT SIZE ON THEIR CONSIGNMENT SHELF. AFTER DISCUSSING ALL TREATMENT OPTIONS WITH THE PHYSICIAN, INCLUDING WEB+STENT OR STENT-COILING IN THIS ACUTE RUPTURED SETTING, IT WAS DETERMINED THAT THE BEST COURSE OF TREATMENT FOR THE PATIENT WAS TO ATTEMPT A 6X3 SL WITH THE LIKELY NEED FOR A STENT TO MAINTAIN VESSEL PATENCY. THE WEB WAS DEPLOYED AND DETACHED WITH SIGNIFICANT PROTRUSION INTO THE BASILAR TRUNK/PCA BIFURCATION. THE DECISION WAS MADE TO PROCEED WITH A STENT PLACEMENT FROM LEFT PCA TO BASILAR TRUNK. POST PROCEDURE DAPT WAS INITIATED PER PHYSICIAN PROTOCOL. THE PATIENT WAS REPORTED TO BE AWAKE WITH NO FOCAL NEURO DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389044 ↗
• DeathMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE PATIENT WAS AN ACTIVE RUPTURE OF AN MCA BIFURCATION ANEURYSM. ANEURYSM WAS NOT AMENABLE TO PRIMARY COILING AND WEB WAS CHOSEN AS THE INTERVENTION. THE TREATING PHYSICIANS DID MEASUREMENTS AND INITIALLY CHOSE A WEB SIZE THAT WAS DEPLOYED BUT DID NOT DETACH AS IT WAS DECIDED WAS TOO LARGE. THE PHYSICIANS THEN OPTED FOR A SMALLER 6X3 WEB SL AND DEPLOYED AND DETACHED IT IN THE ANEURYSM. REPORTEDLY, THE WEB ROTATED AND OCCLUDED A BRANCH VESSEL, WHICH REQUIRED FURTHER INTERVENTION. THE PHYSICIANS OPTED TO BALLOON THE WEB TO REORIENT IT IN THE ANEURYSM BUT MISTAKENLY BALLOONED A FENESTRATION INSTEAD OF THE TARGET VESSEL WITH THE WEB IN IT. UPON BALLOONING THE INCORRECT VESSEL AND THROUGH A FENESTRATION, THE VESSEL RUPTURED CAUSING A MASSIVE SUBARACHNOID HEMORRHAGE. THE PATIENT ICP SHOT UP TO 50+ AND SIGNIFICANT BLOOD OUTPUT WAS NOTED FROM THE ICD. THE END RESULT WAS TO COIL THE RUPTURED VESSEL TO SHUT IT DOWN. THE SAH WAS CONTROLLED AND THE PATIENT WAS TRANSFERRED TO THE NICU FOR OBSERVATION BUT HAD BILATERAL AND BRISK PUPIL RESPONSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Rupture

  MAUDE report 19294311 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH CLINICAL STUDY WEB PAS, THE AE1- FOCAL SEIZURE IS INDICATED AS DEFINITELY RELATED TO THE STUDY PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICE. PATIENT WAS DISCHARGED AT BASELINE A DAY AFTER WEB EMBOLIZATION. PATIENT WAS NOTICED BY SON HAVING DIFFICULTY ANSWERING QUESTIONS, FORMING SENTENCES ON THE DRIVE HOME. AFTER ABOUT 30 MINS PATIENT HAD SLOW IMPROVEMENT BACK TO BASELINE SPEECH BUT THEN HAD REPEAT EPISODES AND WAS ADMITTED TO THE ED. MRI SHOWED MULTIPLE EMBOLI. PATIENT GIVEN HEPARIN DRIP (B)(4) UNITS/HOUR, LACOSAMIDE 50MG TAB BID AND EVENT WAS CONSIDERED RECOVERED/ RESOLVED 3 DAYS AFTER DISCHARGE.

  Patient problems: Convulsion/Seizure; Embolism/Embolus

  MAUDE report 18871397 ↗
• MalfunctionJan 18, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED: PHYSICIAN IMPLANTED THE WEB, AND PURPOSEFULLY PUSHED ON THE WEB TO ENSURE IT WAS FULLY INTRA-ANEURYSMAL. THE VIA CATHETER WAS RETRACTED APPROXIMATELY 2-3CM, THE WDC WAS OPERATED ONCE AND THE DELIVERY WIRE AND THE WEB APPEARED TO IMMEDIATELY SEPARATE, COULD VISIBLY SEE THE DELIVERY WIRE MOVE OFF THE PROXIMAL MARKER UNDER FLOURO. AS PHYSICIAN CAREFULLY PULLED THE DELIVERY WIRE, COULD SEE UNDER FLUOROSCOPY A SEPARATION OF THE WEB DELIVERY WIRE FROM THE WEB PROXIMAL MARKER. WHEN PHYSICIAN HAD RETRACTED ABOUT 2CM OF THE DELIVERY WIRE ¿IT FELT LIKE¿ IT WAS STILL ATTACHED. PHYSICIAN COULD SEE THE APPEARANCE OF THE WEB AND IT WAS CLEAR THE DELIVERY WIRE WAS MOVING THE WEB. PHYSICIAN ADVANCED THE VIA CATHETER BACK OVER THE DELIVERY WIRE NOTING IT FELT ODD AND ATTEMPTED TO DETACH WEB AGAIN. WHEN PHYSICIAN TRIED TO RETRACT THE VIA IT SEEMED TO NOT BE DETACHED COMPLETELY. PHYSICIAN EXERTED FORWARD PRESSURE ON THE VIA WHILE RETRACTING THE DELIVERY WIRE AND THE DETACHMENT WAS THEN CLEAR. THE WEB IMPLANT HAD MOVED A SMALL AMOUNT DURING THIS MANEUVER. IT WAS CHECKED BY ANGIOGRAPHY TO ENSURE THAT IN FACT THE WEB POSITION WAS OPTIMAL. PROCEDURE COMPLETED WITHOUT FURTHER ISSUE WITH N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540378 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED DURING AN MCA ANEURYSM TREATMENT, THE WEB BECAME DISLODGED AND REQUIRED A CLIPPING PROCEDURE. THE ANEURYSM SIZE HAD A WIDTH OF 5.25MM, HEIGHT OF 4.7MM, AND NECK OF 4.5MM. THE DOCTOR SELECTED THE WEB SIZE 6X3 SL. THE PHYSICIAN WAS ADVISED TO USE A LARGER SIZED WEB AND THE ADVICE WAS DISMISSED. AFTER A SUCCESSFUL DEPLOYMENT OF THE WEB 6X3, A FINAL CONTRAST RUN WAS COMPLETED ONLY TO FIND THE WEB BECAME DISLODGED INTO THE PARENT VESSEL. THE WEB WAS OCCLUDING THE PARENT VESSEL WHICH RESULTED IN THE DECISION TO MOVE THE PATIENT TO THE OR (OPERATING ROOM) TO PERFORM A CLIPPING PROCEDURE AND REMOVAL OF THE WEB. AFTER THE PROCEDURE, THE PHYSICIAN AGREED THE REASON FOR THE WEB BECOMING DISLODGED WAS DUE TO IMPROPER SIZING OF THE DEVICE. THE PATIENT¿S CLIPPING WENT WELL. THE PATIENT IS FULLY INTACT AND HAD NO COMPLICATIONS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17917206 ↗
• MalfunctionMay 11, 2023Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  IT WAS REPORTED THAT A WEB DEVICE WAS USED FOR TREATMENT OF A BASILAR TIP ANEURYSM. THE WEB WAS PLACED IN THE ANEURYSM AND ATTEMPTED TO BE DETACHED USING A DETACHMENT CONTROLLER, THE DEVICE DID NOT DETACH DESPITE MULTIPLE DETACHMENT ATTEMPTS. THE PHYSICIAN POSITIONED VIA-17 AT PROXIMAL MARKER AND ATTEMPTED TO CHECK TETHER FOR STICKY DETACHMENT, DEVICE ACTED AS IF NO DETACHMENT WAS EVIDENT. THE PHYSICIAN DECIDED TO REMOVE DEVICE AND UPON ATTEMPTING TO RETRIEVE DEVICE INTO THE VIA-17 THE DEVICE DETACHED PARTIALLY IN PARENT VESSEL. THE PHYSICIAN WAS ABLE TO MANIPULATE DEVICE INTO THE ANEURYSM BUT DEVICE INVAGINATED AND PHYSICIAN PERFORMED A CONTRAST RUN AND CONFIRMED DEPLOYED DEVICE IN THE ANEURYSM. THE PATIENT WAS STABLE WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910990 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF AN ACOM ANEURYSM, THE WEB WAS DETACHED WITHOUT INCIDENT. AFTER DEPLOYMENT THE ACA IS PATENT WITH A SMALL CLOT IN THE VESSEL. AFTER 15 MINUTES, THE ACA CLOSED DUE TO THROMBOTIC EVENT. INTEGRILLIN WAS USED TO RE-OPEN THE ACA. THE PATIENT WAS REPORTED TO BE DOING GREAT. NO PATIENT HARM WAS REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16381248 ↗
• InjurySep 28, 2022Difficult to Remove; Difficult or Delayed Separation; Difficult to Remove; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE WAS USED FOR TREATMENT OF AN ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA). REPORTEDLY, WHEN THE WEB WAS PLACED IN THE ANEURYSM AND ATTEMPTED TO BE DETACHED USING A DETACHMENT CONTROLLER, THE DEVICE DID NOT DETACH DESPITE MULTIPLE DETACHMENT CYCLE AND A SECOND DETACHMENT CONTROLLER. THE PHYSICIAN ADVANCED A MICROCATHETER WITH TENSION ON THE WIRE BUT THE WEB CAME BACK OUT OF ANEURYSM INTO PARENT VESSEL WHILE STILL ATTACHED TO DELIVERY WIRE. THE PHYSICIAN WAS UNABLE TO RE-SHEATH THE WEB INTO THE MICROCATHETER. REPORTEDLY, THE WEB DETACHED INTO THE PARENT VESSEL WHEN A SUPPORT CATHETER WAS BROUGHT UP TO RE-SHEATH THE DEVICE. MULTIPLE ATTEMPTS TO REMOVE THE WEB WITH A SNARE DEVICE FAILED. THE PHYSICIAN DECIDED TO BRING THE WEB TO A SAFE LOCATION IN THE ICA AND SUCCESSFULLY DEPLOYED A WALLSTENT ACROSS TRAPPING AND SECURING THE WEB DEVICE. THE PATIENT WAS STABLE, NEUROLOGICALLY INTACT, AND WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499446 ↗

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.