Stent LEV2517-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429117750), received between Jan 10, 2024 and Jun 7, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CAR REGISTRY STUDY THAT THE SUBJECT EXPERIENCED A BLISTER ANEURYSM. AN ATTEMPT WAS MADE TO TREAT THE ANEURYSM BY COILING, AND THEN AFTER THE COILS KEPT FALLING OUT DUE TO THE ANEURYSM TYPE. THE PHYSICIAN THEN PLACED AN LVIS STENT TO CONDUCT STENT ASSISTED COILING TO TREAT THE ANEURYSM. AT 31 DAYS POST PROCEDURE, FLUOROSCOPIC IMAGING REVEALED THE DEVELOPMENT OF IN STENT STENOSIS. THIS COMPLICATION WAS TREATED WITH A THROMBECTOMY. THE OUTCOME WAS RESOLVED. IT WAS NOTED: EVENT NUMBER: 1 ADVERSE EVENT TERM: IN STENT PARTIAL OCCLUSION RELATIONSHIP TO STUDY DEVICE: RELATED RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: DEFINITELY RELATED RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED RELATIONSHIP TO STUDY DISEASE: NOT RELATED RELATIONSHIP TO CONCURRENT DISEASE: NOT RELATED RELATIONSHIP TO DUAL ANTIPLATELET THERAPY: NOT RELATED. PLEASE NOTE THAT THE COILS USED TO TREAT THE BLISTERING ANEURYSM ARE CONSIDERED NOT RELATED TO THE STUDY DEVICE. THEY ARE CONSIDERED ANCILLARY DEVICES USED IN THIS CASE. THE STENT USED IN THIS CASE IS CONSIDERED TO BE RELATED TO THE STUDY DEVICE, LVIS EVO.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25422363 ↗
• InjuryMay 30, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE STENT IMPLANT DATE IS (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119697 ↗
• MalfunctionJan 10, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE LVIS EVO COULD NOT BE RECAPTURED IN THE MICROCATHETER. STENT / COIL PROCEDURE (ACOMM). A STENT / COIL PROCEDURE WAS PERFORMED TO TREAT AN ACOMM ANEURYSM. THE MICROCATHETER WAS USED IN A "JAILED" TECHNIQUE TO DELIVER LVIS EVO. A SEPARATE MICROCATHETER WAS USED TO DELIVER ONE COIL. WHEN DELIVERING LVIS EVO, PHYSICIAN ATTEMPTED TO RECAPTURE PARTIALLY DEPLOYED (APPROXIMATELY 1/3 TO 1/2) STENT TO REPOSITION THE EVO. THE STENT WOULD NOT RECAPTURE BACK INTO THE MICROCATHETER. STENT WAS DELIVERED DUE TO NOT BEING RECAPTURABLE. THE PATIENT IS DOING WELL AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126084 ↗
• MalfunctionMay 14, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED DURING TREATMENT WITH A FLOW DIVERTER, UPON RESHEATHING THE DISTAL END, A COMPETITORS' MICROCATHETER KICKED BACK PROXIMALLY. THE PHYSICIAN THEN DECIDED TO RECAPTURE THE DEVICE TO REPOSITION DISTALLY AND THE STENT COULD NOT BE RECAPTURED COMPLETELY. THE STENT WAS ABLE TO BE PARTIALLY RECAPTURED WITH THE COMPETITORS MICROCATHETER AND BOTH THE STENT AND MICROCATHETER WERE COMPLETELY REMOVED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316973 ↗
• MalfunctionJan 10, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR PREVIOUSLY COILED ANEURISM THAT REOCCURRED AND NEEDED MORE COILS AT UNSPECIFIED LOCATION. DURING PROCEDURE, THE COIL ASSIST LVIS EVO STENT SHOWED SOME RESISTANCE GOING THROUGH THE HEADWAY-17 MICROCATHETER. THE STENT DEPLOYED FINE BUT WAS UNABLE TO BE RE-SHEATHED DURING RE-POSITIONING ATTEMPT. THE ENTIRE SYSTEM WAS PULLED BACK IN ORDER TO MOVE THE STENT INTO PLACE FOR DEPLOYMENT. THE STENT WAS SUCCESSFULLY DETACHED AND IMPLANTED. OUTCOME WAS IDEAL AND PATIENT DID GREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490104 ↗