Stent LEV3018-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842429117781), received between Jun 1, 2024 and Sep 24, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 50876580 ↗
• InjuryMar 25, 2026Material Fragmentation

  AS REPORTED: STENT WAS PLACED WITH DIFFICULTY, HOWEVER, POST IMPLANTATION ANGIOS SHOWED A SUCCESSFUL PROCEDURE. LATER, SMALL STRANDS WERE NOTED ON CT. PHYSICIAN ASSUMES THAT THESE STRANDS WERE FROM A PART OF THE STENT THAT HAD BROKEN OFF. PATIENT HAD A STROKE BUT HAS SUBSEQUENTLY RECOVERED ASIDE FROM SOME LINGERING ARM NUMBNESS. NO INTERVENTION WAS PERFORMED ON THE STROKE NOR IS ONE PLANNED. THE PATIENT HAS MOSTLY IMPROVED NOW. PHYSICIAN ATTRIBUTES THE STROKE TO THE OVERALL DIFFICULTY OF THE CASE, NOT TO THE LVIS EVO. PHYSICIAN HAD TO DO SIGNIFICANT MANIPULATION OF THE CATHETER AND WIRE TO GET ACCESS AND THE PLACEMENT WAS TOUGH, SO HE THINKS THAT CAUSED THE STROKE.

  Patient problems: Numbness

  MAUDE report 24694029 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: STENT WAS PLACED WITHOUT INCIDENT. PATIENT WAS ON ASPIRIN AND PLAVIX FOR SIX MONTHS POST-PROCEDURE. PATIENT CEASED TAKING PLAVIX AFTER 6-MONTH FOLLOW-UP AND SUFFERED A STROKE WITHIN A FEW WEEKS. PATIENT HAD A FOLLOW UP ANGIO ON IN (B)(6) 2025 AND NO IN-STENT STENOSIS OR INTIMA HYPERPLASIA WAS OBSERVED. THEY PRESENTED IN (B)(6) WITH LEFT MCA DISTRIBUTION STROKES. THE PATIENT STATUS WAS REPORTED TO BE UNCHANGED.

  Patient problems: Ischemia Stroke

  MAUDE report 24031902 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED: REGARDING THE STENT USED, PER THE STAFF, LVIS GOT STUCK IN STENT & CATHETER. LVIS WAS IMPLANTED.

  Patient problems: Hydrocephalus; Intracranial Hemorrhage; Paresis; Ruptured Aneurysm

  MAUDE report 22120095 ↗
• InjuryApr 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE WEB WAS USED TO TREAT THE PATIENT WITH AN MCA ANEURYSM. AFTER THE WEB WAS PLACED, A STENT NEEDED TO BE USED AS THERE WAS A SLOW FILLING OF THE INFERIOR BRANCH. THE DOCTOR HAD TO POST DILATE THE STENT WITH A BALLOON DUE TO A TIGHTENED APPEARANCE IN THE INFERIOR BRANCH. THE BRANCH TEMPORARILY CLOSED DOWN FOR 5 MINS. THE PATIENT DID HAVE COLLATERALS FILLING. A CLOT DEVELOPED AT THE PROXIMAL WEB MARKER & M2 SUPERIOR BRANCH AND INTERGILLIN DRIP WAS ADMINISTERED OVERNIGHT TO TREAT THE CLOT. THE BLOOD PRESSURE READING WAS AT 140, SO THE MEDICATION WAS SWITCHED TO BRILINTA. THEIR P2Y12 WAS 178. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21859030 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 WEEKS POST IMPLANT OF LVIS EVO 3.0 X 18MM PATIENT PRESENTED TO AN OUTSIDE HOSPITAL WITH ACUTE THROMBOSIS OF M2 BRANCH OF TREATED ANEURYSM SITE. ADDITIONAL INFORMATION RECEIVED 09JUL2024: NO INTERVENTION WAS PERFORMED AT THE TIME OF DISCOVERY. THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH DEFICIT OUTSIDE OF THE INTERVENTION TIME WINDOW. THE PATIENT HAD A COMPLETED STROKE OF A LEFT M2 BRANCH.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 19697845 ↗
• MalfunctionJun 1, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT WAS PLACED TOO FAR DISTAL, AND THE PHYSICIAN TRIED TO RESHEATH THE DEVICE, BUT IT WAS UNABLE TO BE RETRIEVED. THE STENT HAD TO BE LEFT WHERE IT WAS PLACED LANDING ON THE SHORT SIDE WITH A COMPETITOR STENT IN THE ACOM LOCATION. THERE WAS NO PATIENT INJURY OR INTERVENTION. THE PATIENT CONDITION WAS REPORTED AS BACK TO BASELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443545 ↗