LVIS 212525-LVIS-D-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429100882), received between Mar 6, 2025 and Feb 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 18, 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.

• 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 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE LVIS PAS STUDY: "ANEURYSM RETREATMENT - ELECTIVE ADMISSION FOR RE-TREATMENT OF RECURRENT RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSMS". EVENT DESCRIPTION: IR COILING OF RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSMS. LVIS USED AS A SOLITARY FLOW DIVERTER. ANEURYSM RETREATMENT ACTUALLY CONSISTED OF ANEURYSM COIL INSERTION WITH THE INDEX STENT USED FOR ASSISTANCE AFTER ANEURYSM PROGRESSED (FAILED FLOW DIVERSION EFFECT). OUTCOME: RESOLVED WITHOUT SEQUELAE. DATE OF INDEX PROCEDURE: (B)(6) 2017. EVENT ONSET DATE: (B)(6) 2018. EVENT LOCATION: IPSILATERAL TO TARGET LESION. SITE DETERMINED AE RELATEDNESS: STUDY DEVICE RELATED. DISEASE RELATED.

  Patient problems: Aneurysm expansion

  MAUDE report 22503766 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED THROUGH "LVIS PAS CLINICAL STUDY" SUBJECT WITH INDEX PROCEDURE ON (B)(6) 2018 FOR ANTERIOR COMMUNICATING ARTERY ANEURYSM WAS NOTED MILD TO MODERATE IN-STENT STENOSIS ON DSA PERFORMED AT FOLLOW UP VISIT 2 ON (B)(6) 2019 (POD 126), RELATED TO INTIMAL HYPERPLASIA, EXPECTED AT THIS INTERVAL FROM TREATMENT. DSA NOTED 1-49%. SLIGHT DISTAL MIGRATION OF THE PROXIMAL STENT, WITH NON-FLOW DIVERTING SEGMENT CROSSING THE NECK OF THE RESIDUAL ANEURYSM. SUBJECT WAS DISCHARGED FROM INDEX PROCEDURE ON (B)(6) 2018. DSA PERFORMED ON (B)(6) 2019 AT FOLLOW UP VISIT-3 NOTED NO STENT STENOSIS AND NO STENT MIGRATION. SITE REPORTED AE AS NOT SAFE, GRADE 1 SEVERITY, STUDY DEVICE-RELATED, NO TREATMENT WAS REQUIRED, WITH OUTCOME OF RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. SUBJECT WAS EXITTED FROM STUDY ON (B)(6) 2024 AFTER COLLECTING 5 YEAR DATE RETROSPECTIVELY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21542475 ↗