Stent LEV3024-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429117798), received between Apr 3, 2024 and May 20, 2025 — classified as 2 injuries, 2 malfunctions.

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 16, 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.

• InjuryMay 20, 2025Device Stenosis; Device Stenosis

  AS REPORTED: SIX MONTHS FOLLOW-UP SHOWED SEVERE IN STENT STENOSIS OF TREATED VESSEL ALONG WITH STENOSIS OF JAILED VESSEL. PATIENT WAS ON DAPT PROTOCOL AND WILL CONTINUE ON DAPT FOR ANOTHER SIX MONTHS. PATIENT IS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050321 ↗
• MalfunctionMay 9, 2024Retraction Problem; Retraction Problem

  AS REPORTED: PHYSICIAN WAS DOING AN SAC OF AN MCA ANEURYSM WITH LVIS EVO. DURING LVIS EVO DEPLOYMENT, PHYSICIAN ATTEMPTED TO RE-SHEATH DEVICE FOR REPOSITIONING AND COULD NOT RE-SHEATH DEVICE. PHYSICIAN WAS ABLE TO BRING UP THE SOFIA CATHETER FOR SUPPORT AND BRING THE HEADWAY 17 ADVANCED MICROCATHETER INTO THE SOFIA WHERE HE WAS ABLE TO RE-SHEATH THE LVIS EVO. PHYSICIAN COMPLETED CASE WITH A NEW LVIS EVO AND A NEW HEADWAY 17 WITHOUT INCIDENT. PATIENT IS STABLE, NO ADVERSE EVENTS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280685 ↗
• MalfunctionApr 29, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT A STENT WAS IMPLANTED IN THE RIGHT M2 SEGMENT OF THE SUPERIOR DIVISION BRANCH. AFTER IT WAS DEPLOYED, IT WAS NOTICED THAT A 2MM SEGMENT OF THE STENT WAS NOT OPENED PROPERLY. NO ATTEMPTS TO OPEN IT WERE MADE AND THE PHYSICIAN DID EXPRESS ANY CONCERNS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199481 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STENT WAS USED FOR A Y STENT TREATMENT OF AN ANEURYSM OF THE LEFT MCA BIFURCATION. THE STENT WAS PLACED IN THE INFERIOR M2 AND DEPLOYED THROUGH A COMPETITOR¿S STENT. THERE WERE NO ISSUES WITH THE TREATMENT. THE STENT LATER DEVELOPED THROMBUS AND THE PATIENT WAS TREATED WITH AN ADDITIONAL COMPETITOR STENT DEPLOYED THROUGH THE STENT TO RESTORE FLOW TO THE VESSEL. THE PATIENT WAS REPORTEDLY SENT FOR A HEMI-CRANIOTOMY AND THEIR LEVEL OF RECOVERY AND THE DEGREE TO WHICH THEY REGAIN FUNCTION IS BEING MONITORED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19038443 ↗