LVIS 214035-LVIS-D-HDERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812636022239), received between Nov 7, 2024 and Mar 30, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Structural Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: TARGET ANEURYSM RUPTURE AND RETREATMENT: LEFT CAROTID CAVERNOUS FISTULA FROM LEFT INFERIOR PETROSAL SINUS WITH COMPLETE OBLITERATION OF THE LEFT CAVERNOUS ICA ANEURYSM, VISIT TO THE EMERGENCY ROOM COMPLAINING OF THE WORST HEADACHE OF HER LIFE. TARGET CAVERNOUS ANEURYSM TREATED WITH STENT ONLY, GOES ON TO RUPTURE WITH DEVELOPMENT OF CCF AND UNDERGOES TRANSVENOUS TREATMENT. THE SEVERITY OF THE EVENT WAS A GRADE 3. ADVERSE EVENT NOT ASSOCIATED WITH A NEUROLOGICAL DEFICIT. THE EVENT LOCATION WAS IPSILATERAL TO TARGET LESION. THE EVENT WAS NOT A TRANSIENT ISCHEMIC ATTACH (TIA) OR STROKE, TARGET ANEURYSM REBLED. THE INDEX PROCEDURE WAS PERFORMED SEVEN AND A HALF MONTHS PRIOR. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS ADJUDICATED TO BE RELATED TO THE STUDY DEVICE, STUDY PROCEDURE, AND DISEASE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 22066997 ↗
• MalfunctionNov 7, 2024Structural Problem; Structural Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: WHEN THE LVIS BLUE STENT WAS DEPLOYED, THE PROXIMAL LUMEN LANDED IN THE HORIZONTAL SEGMENT OF THE CAVERNOUS LEFT ICA. THE STENT DID NOT APPEAR COMPLETELY EXPANDED ALONG THE ANTERIOR GENU OF THE CAVERNOUS ICA. THE EVENT (INCOMPLETE OPENING OF THE LVIS) OCCURRED AFTER DETACHMENT OF THE STENT. PATIENT DID NOT REQUIRE A TREATMENT/INTERVENTION AS A RESULT OF THE EVENT AND WAS DISCHARGED THE NEXT DAY. SITE REPORTED 2 EVENTS FOR THE PATIENT. EVENT #1: WEAKNESS/NUMBNESS PATIENT COMPLAINED OF RIGHT ARM WEAKNESS AND NUMBNESS (EIGHT DAYS POST-OP), MODERATE SEVERITY, TREATED WITH MEDICATION. NEURO-EVALUATION NOTED MRS OF 2 (SEVEN DAYS POST-OP). RESOLVED WITHOUT SEQUELAE WITH NEURO-EVALUATION NOTED MRS OF 1 (6 MONTHS POST OP). EVENT #2: HEADACHE PATIENT COMPLAINED OF INTERMITTENT, NONSPECIFIC HEADACHES - MILD TO MODERATE SEVERITY (1334 DAYS POST-OP). NO TREATMENT WAS REQUIRED, WITH OUTCOME OF ONGOING. PATIENT EXITED STUDY AFTER COMPLETING THE 5 YEAR FOLLOW UP. THE WEAKNESS/NUMBNESS AND HEADACHE WERE DETERMINED TO BE NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED: THE EVENT (INCOMPLETE OPENING OF THE LVIS) OCCURRED AFTER DETACHMENT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626284 ↗