LVIS 213025-LVIS-D-HDERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812636022215), received between Sep 13, 2016 and Nov 6, 2025 — classified as 2 deaths, 4 injuries.

The most frequently reported specific device problem is “Activation 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900741 ↗
• InjuryJun 6, 2018Difficult or Delayed Positioning; Difficult to Remove; Stretched; Difficult or Delayed Positioning; Difficult to Remove; Stretched

  IT WAS REPORTED THAT STENT IMPLANTATION WAS ATTEMPTED IN THE CAROTID SIPHON. DURING DEPLOYMENT, THE LVIS STENT WAS NOT OPENING PROPERLY AROUND THE FIRST BEND; THEREFORE, AN ATTEMPT WAS MADE TO WITHDRAW THE STENT BACK INTO THE MICROCATHETER FOR REPOSITIONING. DURING RETRACTION OF THE DELIVERY PUSHER WIRE, THERE WAS NO EFFECT ON THE STENT AND THE PUSHER WIRE CAME OUT OF THE MICROCATHETER, LEAVING PART OF THE STENT DEPLOYED IN THE VESSEL AND PART OF THE STENT IN THE MICROCATHETER. AN ATTEMPT WAS MADE TO REMOVE THE MICROCATHETER AND THE STENT TOGETHER AS A SINGLE UNIT; HOWEVER, THE DISTAL END OF THE STENT REMAINED AFFIXED TO THE VESSEL WALL. THE PROXIMAL END OF THE STENT STRETCHED AND NARROWED DOWN AS THE MICROCATHETER WAS REMOVED, AND WAS NOT FULLY APPOSED TO THE VESSEL WALL. APPROXIMATELY ONE HOUR AFTER THE PROCEDURE, A CLOT FORMED AND THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK WITH SIGNS OF HEMIPARESIS. ADVANCED IMAGING WAS PERFORMED, WHICH CONFIRMED FLOW ABNORMALITIES NEAR THE STENT, AND THE PATIENT WAS TREATED WITH HEPARIN. CURRENTLY, THE PATIENT IS REPORTED TO BE FINE.

  Patient problems: Ischemia; Thrombus

  MAUDE report 7576479 ↗
• DeathNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS BEING TREATED FOR A HIGH-GRADE (90%) STENOTIC ATHEROSCLEROTIC PLAQUE IN THE LEFT MCA. AFTER THE FIRST INFLATION WITH A BALLOON (NON-MICROVENTION), THERE WAS SIGNIFICANT IMPROVEMENT OF FLOW; HOWEVER, 80% STENOSIS REMAINED. A SECOND, LARGER BALLOON (NON-MICROVENTION) WAS ADVANCED AND INFLATED AT THE SAME SITE. A POST-DILATATION ANGIOGRAM REVEALED ACTIVE CONTRAST EXTRAVASATION FROM A RUPTURED MCA. THE LVIS STENT WAS SUCCESSFULLY DEPLOYED WITHOUT COMPLICATIONS AT THE BLEEDING SITE AS TREATMENT FOR THE BLEEDING, FOLLOWED BY COIL EMBOLIZATION AND TOTAL OCCLUSION OF THE M1 ARTERIAL SEGMENT. FOLLOW-UP ANGIOGRAM DEMONSTRATED TOTAL RESOLUTION OF THE EXTRAVASATION, AND THE BALLOON AND MICROCATHETER WERE REMOVED. NO FURTHER THERAPY WAS ADMINISTERED TO THE PATIENT PER THE FAMILY'S REQUEST DUE TO THE POOR PROGNOSIS. THE CLINICAL RESEARCH NURSE REPORTED THAT THE PATIENT DIED; HOWEVER, THE DEATH WAS A RESULT OF THE PROCEDURE AND WAS NOT CAUSED BY THE LVIS.

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 7023178 ↗
• DeathSep 13, 2016Break; Failure to Advance

  IT WAS REPORTED THE PATIENT PRESENTED WITH A RUPTURED SAH. IT WAS DETERMINED THAT THE RIGHT ARTERY WAS THE VESSEL THAT MOST LIKELY RUPTURED DUE TO PREVIOUS IMAGING. A DUO 156 WAS JAILED IN THE ANEURYSM. THIS WAS SUBSEQUENTLY REMOVED. A 4.5 X 23 LVIS DEVICE WAS PLACED THROUGH A HEADWAY 21 MICROCATHETER. IT WAS ADVANCED AND PROPERLY POSITIONED FOR DEPLOYMENT WITH NO ISSUES. THE DISTAL END OF STENT OPENED WITHOUT ISSUES. UPON GOING AROUND THE CURVE THE STENT WOULD NOT OPEN. THE STENT WAS RESHEATHED AND ANOTHER ATTEMPT WAS MADE. SAME ISSUE OCCURRED AT EXACTLY THE SAME SPOT IN THE CURVATURE OF THE VESSEL. STENT WAS RESHEATHED AND REMOVED FROM PATIENT. A SECOND LVIS DEVICE WAS ATTEMPTED. THE MICROCATHETER AND STENT WERE PLACED PROPERLY AND DEPLOYMENT WAS ATTEMPTED AGAIN. THE STENT WAS DEPLOYING DISTALLY BUT APPEARED NOT TO BE OPENING ALL THE WAY. DURING SECOND ATTEMPT, THE COMPONENTS OF THE STENT CAME APART. THE STENT WAS RESHEATHED AND REMOVED. IT APPEARS THE EXPOSED GUIDE CAUSED A RUPTURE OF THE SECOND ANEURYSM. TO CONTROL THE BLEEDING AN ARTERY HAD TO BE PERMANENTLY OCCLUDED, THUS BLOCKING BLOOD FLOW TO AREAS OF THE BRAIN FED BY THIS ARTERY. THE THIRD ATTEMPT WAS MADE WITH AN ENTERPRI

  Patient problems: Aneurysm; Death

  MAUDE report 5948145 ↗