LVIS 213015-LVIS-D-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429100943), received between May 1, 2025 and Oct 16, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Activation Failure” (2 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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 THE MICROWIRE WAS WITHDRAWN AND A 4.5MM X 18MM LVIS STENT WAS POSITIONED WITHIN THE MICROCATHETER FROM THE RIGHT INTERNAL CAROTID ARTERY BIFURCATION TO THE RIGHT DISTAL CAVERNOUS SEGMENT.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 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE CLINICAL STUDY LVIS PAS THAT INSTANT THROMBUS FORMATION WAS OBSERVED WITHIN THE DISTAL CAVERNOUS SEGMENT AND THE PROXIMAL OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. INTRAOPERATIVE INSTENT THROMBUS OCCURED, REQUIRING IV BOLUS AND MAINTENANCE INFUSION OF IV CANGRELOR, WHICH RESOLVED THE THROMBUS. THE PATIENT WAS NEUROLOGICALLY INTACT POST-OPERATIVE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22925342 ↗
• InjuryJun 4, 2025Activation Failure; Activation Failure

  AS REPORTED VIA THE LVIS PAS CLINICAL STUDY, A TECHNICAL EVENT HAS BEEN REPORTED FOR SUBJECT: (B)(6) AT SITE USA-02. DATE OF MALFUNCTION/DEFICIENCY: ON (B)(6) 2023. TYPE OF DEVICE MALFUNCTION/DEFICIENCY: INCOMPLETE OPEN OF THE LVIS DEVICE DISTAL TO THE ANEURYSM DESCRIPTION: TECHNICAL EVENT: INCOMPLETE LEADING-EDGE EXPANSION WAS CORRECTED WITH THE AID OF A SOLITAIRE DEPLOYED DISTALLY ENABLING INNER CURVE TRACTION. FURTHER PATIENT OUTCOME CONDITIONS REPORTED THAT, MEDICATION WAS NOT GIVEN TO CORRECT THE DEVICE DEFICIENCY. PATIENT FURTHER CONDITION REPORTED AS, ON (B)(6) 2024 (POD 312) PATIENT COMPLAINED OF WORSENING ARM/HAND WEAKNESS (LEFT WORSE THAN RIGHT BUT NOW AFFECTING RIGHT MORE), PARESTHESIA OF THE ARMS/HANDS, PROGRESSIVE WEAKNESS OF THE LEGS, WORSENING HANDWRITING, AND DIFFICULTY WITH FINE MOTOR MOVEMENTS. SITE REPORTED COMPLAINTS WITH AE NAME: ¿MOTOR ISSUES¿, AS NON-SERIOUS, GRADE 1 MILD, UNKNOWN RELATIONSHIP, NO TREATMENT REQUIRED, RESOLVED WITH SEQUELAE ON (B)(6) 2025.

  Patient problems: Muscle Weakness/Atrophy; Paresthesia

  MAUDE report 22146587 ↗
• InjuryMay 1, 2025Activation Failure; Activation Failure

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: LVIS PAS SUBJECT 07-011 INDEX PROCEDURE NOTE, OCCURRENCE OF TECHNICAL EVENT OF ¿INCOMPLETELY OPENED PROXIMAL END OF THE LVIS STENT¿. DURING THE REVIEW OF PATIENT 07-011 INDEX PROCEDURE THE BELOW INFORMATION WAS NOTED FROM EMR. "NEXT ATTENTION WAS TURNED TOWARDS THE INCOMPLETELY OPENED PROXIMAL END OF THE LVIS STENT. A J-SHAPED SYNCHRO WIRE WAS NAVIGATED WITHIN THE HEADWAY 21 MICROCATHETER IN AN ATTEMPT TO PURCHASE THE TRUE LUMEN OF THE STENT AND TO EXPAND THE SAME. THIS HOWEVER PROVED UNSUCCESSFUL EVEN WITH A J-SHAPED MICROCATHETER. FINAL RUNS REVEALED CONTINUING RAYMOND 1 OCCLUSION OF THE ANEURYSM WITH THE INCOMPLETELY OPENED STENT IN THE PARENT ARTERY BUT WITH GOOD LUMINAL FLOW WITHOUT OBVIOUS TURBULENCE. THE MICROCATHETERS WERE WITHDRAWN. FINAL POSTEMBOLIZATION ANGIOGRAM REVEALED NO COMPLICATIONS. GUIDE CATHETER WAS REMOVED AND HEMOSTASIS WAS ACHIEVED BY TR BAND. INTRAVENOUS HEPARIN DRIP WAS INITIATED FOR INCOMPLETE DEPLOYMENT OF THE PROXIMAL END OF THE STENT." THE STENT WAS ULTIMATELY DEPLOYED SUCCESSFULLY, DESPITE SOME COMPLICATIONS ENCOUNTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942972 ↗