WEBRecalls & reported problems across all models
Microvention, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 134
- Deaths reported
- 4
- Injuries reported
- 73
- Recalls
- 0
We found 14 models of WEB by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2021 and Sep 10, 2026 — classified as 4 deaths, 73 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (35 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
Reports received per month, all models
Most reported WEB problems
Device problems
- Adverse Event Without Identified Device or Use Problem38
- Difficult or Delayed Separation35
- Separation Failure32
- Device Dislodged or Dislocated23
- Separation Problem4
- Activation Failure3
- Material Deformation3
- Migration3
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- Obstruction/Occlusion9
- Ruptured Aneurysm9
- Aneurysm7
- Hemorrhage/Blood Loss/Bleeding6
- Thrombosis/Thrombus6
- Speech Disorder4
- Aneurysm expansion3
WEB models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WEB W5-4-2-MVI-3Intrasaccular Flow Disruption Device1 death23 reports
- WEB W5-5-2-MVI-3Intrasaccular Flow Disruption Device20 reports
- WEB W5-4.5-2-MVI-3Intrasaccular Flow Disruption Device19 reports
- WEB W5-7-3-MVI-3Intrasaccular Flow Disruption Device1 death16 reports
- WEB W5-6-3-MVI-3Intrasaccular Flow Disruption Device1 death15 reports
- WEB W5-5-3-MVI-3Intrasaccular Flow Disruption Device14 reports
- WEB W5-6-4-MVI-3Intrasaccular Flow Disruption Device1 death6 reports
- WEB W5-5-S-MVI-3Intrasaccular Flow Disruption Device5 reports
- WEB W5-7-4-MVI-3Intrasaccular Flow Disruption Device5 reports
- WEB W5-4.5-3-MVI-3Intrasaccular Flow Disruption Device4 reports
- WEB W5-7-5-MVI-3Intrasaccular Flow Disruption Device4 reports
- WEB W5-4-3-MVI-3Intrasaccular Flow Disruption Device1 report
- WEB W5-6-S-MVI-3Intrasaccular Flow Disruption Device1 report
- WEB W5-7-S-MVI-3Intrasaccular Flow Disruption Device1 report
Recent WEB adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Stenosis
MAUDE report 50724461 ↗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 ↗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 ↗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 ↗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 ↗InjuryApr 6, 2026Device Dislodged or Dislocated
IT WAS REPORTED THROUGH THE WEB POST-APPROVAL STUDY (PAS) THAT A PATIENT EXPERIENCED WEB DEVICE IMPINGEMENT INTO THE PARENT VESSEL DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT THE IMPINGEMENT RESULTED IN APPROXIMATELY 50 PERCENT STENOSIS SECONDARY TO THE WEB DEVICE. DESPITE THIS FINDING, THERE WAS NO REDUCTION IN FLOW TO THE ANTERIOR CEREBRAL ARTERY, AS CONFIRMED BY DELAYED DYNA SCAN IMAGING PERFORMED SERIALLY FOLLOWING DEVICE DETACHMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REPORTED. THE PATIENT OUTCOME WAS REPORTED AS "WAITING FOR DISCHARGE".
Patient problems: Stenosis
MAUDE report 24795703 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE CLINICAL STUDY WEB PAS: ORIGINALLY NOTED AS POSSIBLE, PROBABLE OR CAUSAL RELATION TO STUDY DEVICE OR INDEX PROCEDURE EVENT TERM: RECURRENT R MCA ANEURYSM. THE INDEX PROCEDURE WAS ON (B)(6) 2025. PER THE HOSPITAL, FOLLOW-UP IMAGING IN (B)(6) 2026 SHOWED: 3D ROTATIONAL ANGIOGRAM WITH RIGHT ICA INJECTION DEMONSTRATES A 1.7 X 2.1 MM RESIDUAL RIGHT MCA BIFURCATION ANEURYSM DOME/NECK STATUS POST PRIOR WEB TREATMENT. THERE HAS BEEN NO ADDITIONAL TREATMENT OUTSIDE OF IMAGING DONE TO IDENTIFY ANEURYSM RECURRENCE. CURRENTLY THERE HAS BEEN NO ADDITIONAL TREATMENT AND NONE NOTED TO BE PLANNED. THE PATIENT IS AWAITING 2-YEAR FOLLOW-UP. EVENT START DATE: 21-JAN-2026 WAS THIS A SERIOUS AE? NO INTERVENTION: X WAS THE AE CAUSED BY OR ASSOCIATED WITH A TECHNICAL EVENT? : NO RELATIONSHIP TO STUDY DEVICE: PROBABLE RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLE RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED RELATIONSHIP TO STUDY DISEASE: POSSIBLE RELATIONSHIP TO CONCOMITANT DISEASE: NOT RELATED AE OUTCOME: ONGOING ADDITIONAL AUTO ALERT RECEIVED NOTED: WAS THIS A SERIOUS AE? NO NONE: X RELATIONSHIP TO STUDY DEVICE: CAUSAL THE RECURRENT R MCA ANEURYSM IS NOW INDICATE
Patient problems: Aneurysm expansion
MAUDE report 24391375 ↗MalfunctionFeb 12, 2026Difficult or Delayed Separation
AS REPORTED THROUGH THE WEB PAS SUBJECT WITH SUBJECT NUMBER 04-010. THE IMAGING REPORT INDICATED A TECHNICAL EVENT OCCURRED DURING THE INDEX PROCEDURE. NOTES FROM IMAGING REPORT: WE ENCOUNTERED A STICKY TETHER AND MANAGED IT IN THE TYPICAL FASHION AND THEN REMOVED THE MICROCATHETER FROM THE BODY. POST-DETACHMENT DSA REVEALED A VERY SMALL NECK REMNANT ALONG THE ANTERIOR ASPECT OF THE ANEURYSM, STASIS WITHIN THE ANEURYSM SAC, AND NO EVIDENCE OF ENCROACHMENT UPON THE BRANCH VESSELS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24328782 ↗MalfunctionFeb 10, 2026Separation Failure
IT WAS REPORTED THAT DURING THE PROCEDURE, THE WEB DEVICE WAS DEPLOYED, THE VIA CATHETER WAS RETRACTED, THE WEB DEVICE WAS DETACHED, AND THE PUSHER WIRE WAS REMOVED FROM THE CATHETER. WHEN THE PHYSICIAN RETRACTED THE VIA CATHETER, SOMETHING REMAINED ATTACHED TO THE WEB DEVICE AND CAUSED THE WEB TO BE PULLED SLIGHTLY OUT OF THE ANEURYSM. THE PHYSICIAN THEN INSERTED A WIRE INTO THE VIA CATHETER, AND UNDER FLUOROSCOPIC IMAGING IT WAS OBSERVED THAT THE VIA CATHETER DETACHED FROM THE WEB DEVICE. THE CASE WAS SUBSEQUENTLY COMPLETED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24310573 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE TREATMENT OF AN ACOMM ANEURYSM RUPTURE, MULTIPLE IMAGES WERE OBTAINED TO DETERMINE THE PLACEMENT OF THE WEB AFTER IT HAD DETACHED. INITIALLY, THE IMAGES LOOKED FINE. A FINAL IMAGE WAS TAKEN ABOUT TWENTY MINUTES AFTER DETACHMENT, AND IT REVEALED A SLIGHT SLOWING OF CONTRAST AND BLOOD FLOW PAST THE DEVICE. AGGRASTAT WAS ADMINISTERED TO THE PATIENT, AND EVERYTHING CLEARED UP ABOUT TEN MINUTES AFTER ADMINISTRATION. FINAL IMAGES WERE TAKEN, CONFIRMING ALL VESSELS REMAINED OPEN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER REPEATED VISUALIZATION AND ADMINISTRATION OF AGGRASTAT, THE BLOOD FLOW HAD RESUMED AS NORMAL. IT WAS DETERMINED THAT THERE WAS NO INCURSION OF THE WEB INTO THE PARENT VESSEL. NOTHING ADDITIONAL WAS PERFORMED AFTER RESUMPTION OF NORMAL BLOOD FLOW. THE PATIENT IS DOING WELL AND IS RECOVERING. IMAGES HAVE BEEN REQUESTED; HOWEVER, THEY ARE UNAVAILABLE.
Patient problems: Reduced Blood Flow
MAUDE report 24164931 ↗InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT ENROLLED IN THE WEB PAS CLINICAL STUDY EXPERIENCED ANEURYSM GROWTH DURING FOLLOW UP. THERE IS FILLING OF 5 MM WHEN IT WAS PREVIOUSLY 2 MM AT THE BASE. THERE HAS BEEN NO INTERVENTION AND THERE IS NO REPORTED PATIENT SEQUELAE.
Patient problems: Aneurysm expansion
MAUDE report 23732075 ↗MalfunctionNov 21, 2025Separation Failure; Separation Failure
AS REPORTED: DEVICE WAS TESTED PRIOR TO INSERTION WITH GREEN LIGHT. DEVICE INSERTED INTO MCA ANEURYSM AND WHEN GOING TO DETACH, IT WAS FLASHING GREEN AND THEN RED. TRIED A NEW DETACHER AND WENT THROUGH PROPER CYCLE, BUT NO CLEAR DEFLECTION. WENT TO USE THE MICROCATHETER TO PUSH THE DEVICE OFF AND IT RESHEATHED. SINCE IT RESHEATHED BACK INTO MICROCATHETER, DECIDED TO REMOVE DEVICE ENTIRELY. NEW DEVICE SUCCESSFULLY PLACED. GOOD RESULT, GOOD PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619393 ↗InjurySep 7, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
AS REPORTED THROUGH THE WEB PAS STUDY: ON ROUTINE 6-MONTH POST-IMPLANTATION IMAGING, IT WAS NOTED THAT THE WEB DEVICE WAS MORE COMPACTED THAN PREVIOUSLY SEEN. IT WAS NOTED THAT THE RESIDUAL FILLING AT THE ANEURYSM BASE WAS REDUCED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REPORTED.
Patient problems: Aneurysm expansion; Ruptured Aneurysm
MAUDE report 22989546 ↗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 ↗
Other Microvention, Inc. products
- Azur CX Detachable22 models · 509 reports · 1 recall
- Stent63 models · 237 reports · 2 recalls
- Azur Detachable Helical HydroCoil42 models · 190 reports
- V-Trak75 models · 147 reports
- AZUR14 models · 104 reports
- HydroSoft 3D26 models · 101 reports
- MicroPlex Helical Soft9 models · 8 reports · 1 recall
- ERIC Retrieval Device3 models · 5 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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