LVISRecalls & reported problems across all models

We found 17 models of LVIS by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2016 and Apr 2, 2026 — classified as 3 deaths, 41 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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

Most reported LVIS problems

LVIS models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LVIS 212525-LVIS-D-HDE

  intracranial neurovascular stent
  9 reports
• LVIS 213025-LVIS-D-HDE

  intracranial neurovascular stent
  2 deaths6 reports
• LVIS 212517-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  4 reports
• LVIS 213015-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  4 reports
• LVIS 213015-LVIS-D-HDE

  intracranial neurovascular stent
  1 death3 reports
• LVIS 214035-LVIS-D-HDE

  intracranial neurovascular stent
  3 reports
• LVIS 212525-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  3 reports
• LVIS 213025-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  3 reports
• LVIS 213041-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  3 reports
• LVIS 214035-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  3 reports
• LVIS 212517-LVIS-D-HDE

  intracranial neurovascular stent
  2 reports
• LVIS 212928-LVIS-D-HDE

  intracranial neurovascular stent
  2 reports
• LVIS 214049-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  2 reports
• LVIS 213025-LVIS-C

  intracranial neurovascular stent
  1 report
• LVIS 213025-LVIS

  Intracranial Neurovascular Stent
  1 report
• LVIS 212922-LVIS-D-HDE

  intracranial neurovascular stent
  1 report
• LVIS 212931-LVIS-D-PMA

  Intracranial Coil-Assist Stent
  1 report

Recent LVIS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THERE ARE 3 AE'S HAVE BEEN REPORTED FOR SUBJECT (B)(6) AT SITE USA-06. AN AE HAS BEEN REPORTED FOR SUBJECT (B)(6) AT SITE USA-06. BELOW AE WAS ADJUDICATED ON 10MAR2026 AS STUDY DEVICE-RELATED, STUDY PROCEDURE-RELATED STUDY: LVIS PAS (RETROSPECTIVE STUDY): AE #1 NAME: TRANSIENT OCCLUSION OF RIGHT MCA. EVENT ONSET DATE: 31-OCT-2018. EVENT DESCRIPTION: TRANSIENT OCCLUSION OF RIGTH MCA WITH RESTORATION OF NORMAL FLOW AFTER INFUSION THERAPY FOR THROMBOLYSIS. DATE OF INDEX PROCEDURE: (B)(6) 2018 IS THE EVENT A SERIOUS ADVERSE EVENT: NO. OUTCOME: RESOLVED WITHOUT SEQUELAE. DOES THE EVENT MEET CRITERIA FOR AN UNANTICIPATED ADVERSE DEVICE EFFECT: NO. THE PATIENT OUTCOME WAS BASED ON DISCHARGE SUMMARY ON (B)(6) 2018 PATIENT WORKED WITH PT/OT AND DID WELL ENOUGH TO BE DISCHARGED HOME WITH SUPERVISION. HAS HEADACHES WHICH WILL BE MANAGED CONSERVATIVELY. BELOW AE # 4 WAS ADJUDICATED ON (B)(6) 2026 AS STUDY DEVICE-RELATED, STUDY PROCEDURE-RELATED. STUDY: LVIS PAS (RETROSPECTIVE STUDY): AE #4 NAME: HYPOPERFUSION. EVENT ONSET DATE: 14-MAR-2019. EVENT DESCRIPTION: HYPOPERFUSION EVENT RELATED TO RIGHT CAROTID OCCLUSION. PRESENTED AS A MINOR STROKE WITH

  Patient problems: Headache; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 24772272 ↗
• InjuryMar 30, 2026Activation Problem

  SEE H11.

  Patient problems: Hematoma; Speech Disorder; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 24709097 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: PATIENT BEGAN TO REPORT DIPLOPIA; FOUND TO HAVE 9 MM RECURRENCE OF ANEURYSM. PATIENT OUTCOME WAS RESOLVED WITH SEQUELAE. THE EVENT WAS ADJUDICATED AS RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. INDEX PROCEDURE WAS PERFORMED TWO YEARS PRIOR. RECURRENT ANEURYSM WAS TREATED WITH SUCCESSFUL FLOW DIVERTER STENT-ASSISTED COIL EMBOLIZATION OF RECURRENT LEFT PCOM ANEURYSM THIRTY-SEVEN (37) DAYS AFTER REPORT OF DIPLOPIA. SITE DID NOT PROVIDE THE OPERATIVE REPORT. SITE DID NOT PROVIDE ANY PROGRESS NOTE. PATIENT HAD MRA TWO YEARS AFTER RETREATMENT, TARGET ANEURYSM WAS RAYMOND 3, 95% OCCLUSION, NO IN-STENT STENOSIS, NO STENT MIGRATION.

  Patient problems: Aneurysm

  MAUDE report 24709031 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY, AN ADVERSE EVENT OF THE PATIENT EXPERIENCING SOME RESIDUAL NECK AND PROXIMAL DOME FILLING OF THE ANEURYSM BASE BETWEEN THE COILS. THE DATE OF INDEX PROCEDURE WAS (B)(6) 2021. THE EVENT WAS RESOLVED BY DECIDING TO OBSERVE BY ROUTINE SURVEILLANCE ANGIOGRAPHY. THE PATIENT OUTCOME IS THAT THEY HAD ANOTHER DIAGNOSTIC CEREBRAL ANGIOGRAPHY ON (B)(6) 2023, WHICH SHOWED STABLE OCCLUSION OF THE LEFT VERTEBRAL ARTERY ANEURYSM WITH A WIDE, 5MM NECK ARISING FROM THE LEFT VERTEBRAL ARTERY JUST PROXIMAL TO THE VERTEBROBASILAR JUNCTION, WHERE THERE IS A FENESTRATION, BUT WITH SOME RESIDUAL FILLING OF THE ANEURYSM BASE THROUGH THE COILS, RAYMOND 2A.

  Patient problems: Aneurysm

  MAUDE report 24553404 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN MRI TWO DAYS PRE-PROCEDURE SHOWED NUMEROUS SCATTERED SMALL ACUTE BILATERAL SUPRATENTORIAL INFARCTS WHICH ARE MOST LIKELY EMBOLIC. EMR DOCUMENTATION REFERS TO THEM AS WATERSHED STROKES. THE PATIENT EXPERIENCED LEFT SIDED WEAKNESS, DECREASED ACTIVITY TOLERANCE, IMPAIRED BALANCE AND WAS DISCHARGED FROM THE HOSPITAL TO ACUTE REHAB TO CONTINUE PHYSICAL THERAPY, OCCUPATIONAL THERAPY, MONITORING AND MANAGEMENT OF BLOOD PRESSURES. THE PATIENT DID NOT RECEIVE ANY MEDICATIONS OR FURTHER TREATMENT FOR THIS EVENT. IN A CT HEAD OBTAINED BY REHAB ON NINE DAYS POST PROCEDURE, STATES "SEQUELA OF PRIOR WHITE MATTER INFARCTS SUPRATENTORIALLY AGAIN IDENTIFIED WITHOUT INCREASE.

  Patient problems: Aneurysm expansion; Headache; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Hydrocephalus; Muscle Weakness/Atrophy; Reduced Blood Flow

  MAUDE report 24470841 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THAT THE FOLLOWING AE FOR AN LVIS SUBJECT WAS ADJUDICATED BY CEC STUDY DEVICE-RELATED: LEFT MCA ISCHEMIC STROKE ON POD 293. THE PATIENT REPORTED THAT THEIR PENMANSHIP HAS BEEN AFFECTED BY RIGHT HAND NUMBNESS. THE LEFT MCA ISCHEMIC STROKE WAS TREATED WITH PLAVIX AND COUMADIN. BASED ON THE REVIEW OF DISCHARGE NOTE, SUBJECT HAD ONGOING SYMPTOMS OF RIGHT-HAND NUMBNESS AS OF THEIR DISCHARGE DATE (B)(6) 2021.

  Patient problems: Ischemia Stroke; Numbness

  MAUDE report 24424478 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE CLINICAL STUDY LVIS PAS: AE FOR LVIS SUBJECT WAS ADJUDICATED BY CEC 02-FEB-2026, AS STUDY PROCEDURE-RELATED AND STUDY DEVICE-RELATED. AE NAME: NECK REMNANT VS. RECANALIZATION DATE OF INDEX PROCEDURE: ON (B)(6) 2017. EVENT ONSET DATE: 6-SEP-2018. EVENT DESCRIPTION: FROM CTA NECK ON (B)(6) 2018: STATUS POST STENT ASSISTED COILING OF PREVIOUSLY DEMONSTRATED ANEURYSMS ARISING FROM THE RIGHT POSTERIOR CEREBRAL ARTERY AT THE P2-P3 SEGMENTS. THERE IS A SMALL AREA OF RECANALIZATION VERSUS NECK REMNANT JUST SUPERIOR TO THE COIL MASS ON SERIES 5 IMAGE 110 MEASURING 3 MM DIAMETER. DURING FOLLOW UP VISIT ON (B)(6) 2018 THE PHYSICIAN REVIEWED HIS CTA FROM EARLIER TODAY. THERE IS A SMALL, 2 MM, RESIDUAL SEEN AT THE NECK OF THE PROXIMAL ANEURYSM AND THE DISTAL ANEURYSM IS NO LONGER SEEN. THE PATIENT IS NOT EXPERIENCING ANY SYMPTOMS. NEUROLOGIST RECOMMENDED CONTINUED XARELTO. DEVICE REMAINS IMPLANTED. SITE REPORTED RELATEDNESS: DISEASE-RELATED IS THE EVENT A SERIOUS ADVERSE EVENT? NO. OUTCOME: RESOLVED WITHOUT SEQUELAE. DOES THE EVENT MEET CRITERIA FOR AN UNANTICIPATED ADVERSE DEVICE EFFECT? NO. NO OTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aneurysm expansion

  MAUDE report 24396465 ↗
• InjuryNov 7, 2025Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  AS REPORTED VIA THE LVIS PAS CLINICAL STUDY: THIS FILE CAPTURES THE SECOND STENT USED IN THE CASE. DURING INDEX PROCEDURE ON (B)(6) 2017, MICROWIRE WAS THEN REMOVED AND THE FIRST OF THE TWO FLOW DIVERTING STENTS WAS THEN LOADED AND APPLIED IN THE FOLLOWING MANNER. FIRST PART OF THE STENT WAS PUSHED OUT OF THE CATHETER SUCH THAT GOOD DISTAL WALL APPOSITION WAS OBTAINED. THE REST OF THE STENT WAS THEN GENTLY PUSHED OUT OF THE CATHETER BUCKFIELD OPEN COMPLETELY IN THE SUPRA-CLINOID ICA SEGMENT, THEN "WAGGED" THE CONSTRUCT A FEW TIMES UNTIL IT OPENED FULLY AND CONTINUED DEPLOYING THE REMAINDER OF THE DEVICE. FOLLOW UP RUNS REVEAL INCOMPLETE STENT APPOSITION ALONG THE ANTERIOR OPHTHALMIC AND CLINOID SEGMENTS. WE THEN USED A J-WIRE TO BUMP THE STENT OPEN AND ALSO GAIN DISTAL ACCESS FOR THE SECOND DEVICE. FOLLOW UP ANGIOGRAPHY AFTER THIS MANEUVER REVEALED COMPLETE APPOSITION OF THE STENT BUT PERSISTENT ANEURYSM FILLING. WE THEN LOADED THE SECOND DEVICE AND STARTED DEPLOYING IT BUT, YET AGAIN, HAD TROUBLE WITH INCOMPLETE OPENING. THE ABOVE-MENTIONED PROCEDURE ¿WAGGING¿ WAS REPEATED WITH ONLY PARTIAL SUCCESS. THE DEVICE WAS CONTINUED BEING DEPLOYED BUT HAD TO REACH SHEATH IT NUMEROUS TIMES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499333 ↗
• InjuryNov 6, 2025Activation Problem; Activation Problem

  AS REPORTED VIA THE LVIS PAS CLINICAL STUDY: DURING INDEX PROCEDURE ON (B)(6) 2017 MICROWIRE WAS THEN REMOVED AND THE FIRST OF THE TWO FLOW DIVERTING STENTS WAS THEN LOADED AND APPLIED IN THE FOLLOWING MANNER. FIRST PART OF THE STENT WAS PUSHED OUT OF THE CATHETER SUCH THAT GOOD DISTAL WALL APPOSITION WAS OBTAINED. THE REST OF THE STENT WAS THEN GENTLY PUSHED OUT OF THE CATHETER BUCKFIELD OPEN COMPLETELY IN THE SUPRA-CLINOID ICA SEGMENT, THEN "WAGGED" THE CONSTRUCT A FEW TIMES UNTIL IT OPENED FULLY AND CONTINUED DEPLOYING THE REMAINDER OF THE DEVICE. FOLLOW UP RUNS REVEAL INCOMPLETE STENT APPOSITION ALONG THE ANTERIOR OPHTHALMIC AND CLINOID SEGMENTS. WE THEN USED A J-WIRE TO BUMP THE STENT OPEN AND ALSO GAIN DISTAL ACCESS FOR THE SECOND DEVICE. FOLLOW UP ANGIOGRAPHY AFTER THIS MANEUVER REVEALED COMPLETE APPOSITION OF THE STENT BUT PERSISTENT ANEURYSM FILLING. WE THEN LOADED THE SECOND DEVICE AND STARTED DEPLOYING IT BUT, YET AGAIN, HAD TROUBLE WITH INCOMPLETE OPENING. THE ABOVE-MENTIONED PROCEDURE ¿WAGGING¿ WAS REPEATED WITH ONLY PARTIAL SUCCESS. THE DEVICE WAS CONTINUED BEING DEPLOYED BUT HAD TO REACH SHEATH IT NUMEROUS TIMES IN THE PROCESS OF DEPLOYMENT AND EVENTUALLY WERE ABLE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493038 ↗
• InjuryOct 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Aneurysm

  MAUDE report 23331631 ↗
• InjuryOct 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE LVIS POST-APPROVAL STUDY ¿ POST-MARKET SURVEILLANCE STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE LVIS® DEVICE THAT THE STENT WAS INCOMPLETELY OPEN AT THE PROXIMAL END. A SYNCRO WIRE WAS USED TO FULLY EXPAND THE END BUT WAS UNSUCCESSFUL. EMBOLIZATION: THE RIGHT INTERNAL CAROTID ARTERY WAS SELECTED AND UNDER ROADMAP GUIDANCE AND 10MG OF VERAPAMIL WAS ADMINISTERED. THE 071 BENCHMARK GUIDE CATHETER WITH A SIMMONS INSERT WAS ADVANCED OVER THE GUIDEWIRE INTO THE CAVERNOUS PORTION OF THE INTERNAL CAROTID ARTERY. THE INSERT AND GUIDEWIRE WERE REMOVED. FOLLOW-UP CONTROL ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED MILD VASOSPASM AROUND THE GUIDE CATHETER. UTILIZING A ROAD MAP A MICROCATHETER WAS NAVIGATED OVER A GUIDE WIRE INTO THE RIGHT MID M1. THE MICROWIRE WAS WITHDRAWN AND A 4.5MM X 18MM LVIS STENT WAS POSITIONED WITHIN THE MICROCATHETER FROM THE RIGHT INTERNAL CAROTID ARTERY BIFURCATION TO THE RIGHT DISTAL CAVERNOUS SEGMENT. A 45-DEGREE MICROCATHETER WAS NAVIGATED OVER A GUIDEWIRE AND THE ANEURYSM WAS CATHETERIZED. THE FIRST COIL WAS ATTEMPTED TO BE DEPLOYED WITHIN THE ANEURYSM, BUT THIS PROVED EXCEEDINGLY DIFFICULT DUE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319393 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: EVENT SUMMARY: FIVE DAYS AFTER THE INDEX PROCEDURE, MRI BRAIN REVEALED SIGNS OF LEFT CEREBRAL PEDUNCLE STROKE. THERE IS AN INTRAPARENCHYMAL HEMATOMA IN THE RIGHT FRONTAL LOBE; THIS IS UNCHANGED FROM THE RECENT CT EXAMINATION. PNEUMOCEPHALUS WITH AIR BUBBLES IN BOTH LATERAL VENTRICLES IS PRESENT. BASED ON NEUROSURGERY CONSULT, MRI FINDINGS WERE FOUND AS NOT ACUTELY CONCERNING, AND REQUIRED NO CHANGE IN MANAGEMENT. PATIENT REMAINS SEDATED, INTUBATED AND MECHANICALLY VENTILATED. ADDITIONALLY, WITH NO EVIDENCE OF VASOSPASM ON DAILY TRANS CRANIAL DOPPLERS AND CEREBRAL ANGIOGRAM, WAS GIVEN THE OKAY TO BEGIN NORMALIZING BP, AND BEGIN SPONTANEOUS BREATHING TRIALS FOR EXTUBATING. REPEAT MRI, NINE DAYS AFTER THE INDEX PROCEDURE, DEMONSTRATED MULTIPLE SMALL EMBOLIC CVAS. EVENT WAS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS ADJUDICATED AS STUDY DEVICE-RELATED, DISEASE-RELATED AND MEDICATION-RELATED. INDEX PROCEDURE: PATIENT PRESENTED TO ED WITH SAH AND BASILAR ARTERY ANEURYSM, UNDERWENT CEREBRAL ANGIOGRAM WITH STENTING OF BASILAR ARTERY BIFURCATION, COIL EMBOLIZATION OF BASILAR ARTERY ANEURYSM, AND PLACEMENT OF EVD. PATIENT DID SHOW SOME IMPROVEME

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 23307975 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THAT THE SUBJECT UNDERWENT SURGICAL PROCEDURE OF COILING FOR "RECANALIZATION OF TARGET ANEURYSM" APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE. INDEX PROCEDURE WAS (B)(6) 2018 AND THE SUBJECT UNDERWENT SUCCESSFUL BALLOON ASSISTED, LVIS STENT ASSISTED COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY. IT WAS REPORTED THAT THE SUBJECT OUTCOME WAS "METASTASIS" DIAGNOSED ON (B)(6) 2021 WITH OUTCOME OF DEATH ON (B)(6) 2021. THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2021 WITH COMPLAINTS OF CONSTIPATION, VERY POOR PER ORAL INTAKE. METASTASIS LED TO ABDOMINAL ASCITES AND CONSTIPATION COMPLICATED BY ACUTE KIDNEY INJURY, HYPERKALEMIA, HYPONATREMIA AND SEPSIS. THE PATIENT MEDICAL HISTORY IS REPORTED AS: HYPERTENSION, CHRONIC ANEMIA, HISTORY OF HOSPITALIZATION FOR EVALUATION OF MULTIPLE LUNG NODULES AND LIVER MASS.

  Patient problems: Aneurysm expansion

  MAUDE report 23306337 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY AN AE WAS ADJUDICATED AS TARGET ANEURYSM RETREATMENT. CEC COMMENT: RUPTURED ACOMM ORIGINALLY CLIPPED AND TREATED WITH LVIS AS INDEX PROCEDURE. RETREATED IN 2022 WITH A STENT. DATE OF INDEX PROCEDURE: (B)(6) 2019 OUTCOME: RESOLVED WITHOUT SEQUELAE. THE PATIENT WAS RETREATED WITH A STENT ON (B)(6) 2022. POST PROCEDURE EVALUATION ON (B)(6) 2022 PATIENT WAS DOING WELL AND NEUROLOGICALLY INTACT, WAS DISCHARGED HOME. PATIENT HAS A HISTORY OF RIGHT FILLING ACOM AND UNDERWENT SURGICAL CLIPPING FOR (B)(6) IN 2006.

  Patient problems: Aneurysm expansion; Headache; Neuropathy

  MAUDE report 23294873 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H11.

  Patient problems: Extravasation

  MAUDE report 23034149 ↗

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