Stent LEV2522-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429117767), received between Apr 12, 2024 and Jun 8, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (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 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.

• MalfunctionJun 8, 2026Retraction Problem

  IT WAS REPORTED THAT THE COIL-ASSIST STENT WAS BEING USED IN AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM EMBOLIZATION PROCEDURE. THE STENT INTRODUCED INTO THE CATHETER WITHOUT INCIDENT; HOWEVER, WHEN THE PHYSICIAN TRIED TO DEPLOY IT, THE STENT WOULD NOT OPEN DISTALLY. THE PHYSICIAN THEN TRIED TO RECAPTURE THE STENT AND WAS NOT ABLE TO. THE PHYSICIAN REMOVED THE ENTIRE STENT/CATHETER SYSTEM AND USE A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT, WHO WAS REPORTED IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437285 ↗
• InjuryJun 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WOKE UP FROM THEIR PROCEDURE "ABNORMAL" WITH LEFT SIDED ARM AND LEG WEAKNESS. THEY WERE ADMINISTERED ASPIRIN AND PLAVIX AND THEIR MRS SCORE IMPROVED TO 1.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 19544822 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD A STENT IMPLANTED IN THE MCA BIFURCATION WEEKS PRIOR PRESENTED WITH A M2 SEGMENT STROKE. THE STENT HAD STENOSIS AND THROMBUS. A BALLOON COULD NOT BE INSERTED INTO THE CATHETER FOR ANGIOPLASTY DUE TO STENOSIS. IT WAS POSSIBLE TO ASPIRATE THROMBUS AT THE PROXIMAL PART OF THE STENT. THE PATIENT HAS CORE INFARCT AND LEFT-SIDED WEAKNESS.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Stenosis; Thrombosis/Thrombus

  MAUDE report 19218654 ↗
• InjuryApr 12, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT A STENT WAS USED TO TREAT AN ACOMM ANEURYSM. THE OBJECTIVE WAS TO PERFORM A STENT ASSISTED COILING ON A RECANALIZED ACOMM FROM A PRIOR SAH. THE PATIENT'S PRU WAS 38 AND PRETREATED WITH BRILENTA 60MG, STENTED FROM RIGHT A2 TO LEFT A1. THEN THE DOCTOR DEPLOYED HALF OF THE STENT AND ACCESSED THE ANEURYSM WITH A COMPETITOR'S MICROCATHETER AND PARTIALLY DEPLOYED A COMPETITOR'S COIL. IT WAS FALLING OUT OF THE ANEURYSM AND THEN TRIED TO RE-SHEATH THE STENT SO IT COULD SUPPORT THE COIL DEVICE BETTER AND COULD NOT. A CLOT HAD DEVELOPED IN A SHORT TIME FRAME AND FINISHED DEPLOYING THE STENT DEVICE. THEN THE DOCTOR TRIED TO RE-ACCESS ANEURYSM TRANS-STENT WITH A MICROCATHTER AND COULD NOT. AN ANGIO RUN SHOWED SLOW FLOW IN A2 AND THEY GAVE INTEGRILIN BOLUS AND DRIP TO FOLLOW. THE CLOT RESOLVED DURING CASE AND FLOW WAS RESTORED TO BASELINE ANGIOGRAM. FOLLOWED UP LATER THAT DAY AND ONE WEEK LATER AND THE PATIENT WAS REPORTED TO BE GOOD AND WAS DISCHARGED HOME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19094287 ↗