Surpass Elite FDSE45020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327582925), received between Oct 25, 2024 and Jun 9, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A DAY AFTER PROCEDURE, A CORTICAL INFARCTION WAS DETECTED ON DIFFUSION-WEIGHTED IMAGING. SYMPTOMS WERE MILD, AND THE PATIENT WAS DISCHARGED. 10 DAYS POST-PROCEDURE PATIENT WAS RE-ADMITTED WITH TRANSIENT ISCHEMIC ATTACK (TIA) SYMPTOMS. TRANSFEMORAL CEREBRAL ANGIOGRAPHY (TFCA) IMAGING SHOWED INTERNAL CAROTID ARTERY (ICA) ARTERY THROMBUS AND SUBJECT DEVICE FISH-MOUTHING. ANOTHER SURGERY OF THROMBECTOMY WAS PERFORMED BUT WAS UNSUCCESSFUL. MEDICATIONS TIROFIBAN WERE ADMINISTERED INTRAVENOUSLY (IV) AND INTRA-ARTERIALLY (IA). PATIENT PRESENTED WITH ARM WEAKNESS. 2 DAYS POST- THROMBECTOMY PROCEDURE, SYMPTOMS PROGRESSED TO LOWER EXTREMITY WEAKNESS. MORE ICA THROMBUS & SEVERE FISH MOUTHING AND SECOND IA THROMBECTOMY ATTEMPT WAS MADE BUT WAS UNSUCCESSFUL. ADDITIONAL IA TIROFIBAN WAS ADMINISTERED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. PHYSICIAN GAVE FEEDBACK THAT THE SUBJECT DEVICE FISH MOUTHING HAS OCCURRED DUE TO THE BARRELING OF THE STENT, BECAUSE OF THE MORPHOLOGY OF THE ANEURYSM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA; Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 22166003 ↗
• InjuryMay 30, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING ENDOVASCULAR FLOW DIVERTER IMPLANTATION PROCEDURE ON (B)(6) 2024, THERE WAS SOME MAL-APPOSITION OF THE SUBJECT FLOW DIVERTER STENT IN THE FORM OF A LEDGE ON THE PROXIMAL END OF THE SUBJECT STENT. ANOTHER STENT WAS DEPLOYED INSIDE IT TO REDUCE THE LEDGE. ON (B)(6) 2025, IT WAS NOTIFIED THAT FOLLOW UP IMAGING REVEALED THAT THE INTERNAL CAROTID ARTERY COMPLETELY OCCLUDED DUE TO INTIMAL HYPERPLASIA AT THE LEVEL OF THE SUBJECT STENT. THE PATIENT IS WELL AND IS ASYMPTOMATIC. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 22115028 ↗
• MalfunctionOct 25, 2024Activation Failure; Migration; Activation Failure; Migration

  IT WAS REPORTED THAT DURING PROCEDURE FOR INTERNAL CAROTID ARTERY (ICA) PARACLINOID ANEURYSM, WHILE DEPLOYING THE SUBJECT STENT IN THE PROXIMAL POSTERIOR COMMUNICATING ARTERY (PCOM), DISTAL PART WAS NOT OPENED WELL. A BALLOON WAS USED TO FULLY OPEN THE FLOW DIVERTER. 30 MINUTES POST PROCEDURE THE PHYSICIAN FELT LAZY OPENING OF DISTAL PART OF THE SUBJECT FLOW DIVERTER. IT WAS DEPLOYED IN THE PCOM PREVIOUSLY BUT FELL TO THE NECK OF ANEURYSM LATER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535129 ↗