Surpass Elite FDSE40012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327582697), received between Apr 4, 2025 and Aug 6, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS USED ON (B)(6) 2025. THERE WERE NO ISSUES WITH THE SUBJECT DEVICE DURING THE PROCEDURE AS THE SUBJECT DEVICE WAS PREPPED PER IFU. THE PATIENT WAS ON DUAL ANTI PLATELET, NO THROMBOEMBOLIC EVENTS DURING THE PROCEDURE. PROXIMAL END WAS MALPOSED AND AFTER RUNNING THE INTERMEDIATE CATHETER THROUGH THE DEPLOYED SUBJECT DEVICE, GOOD APPOSITION WAS NOTED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT DID VERY WELL AND WAS DISCHARGED ON (B)(6) 2025. POST PROCEDURE ON (B)(6) 2025, THE PATIENT DEVELOPED STROKE LIKE SYMPTOMS AND A MECHANICAL THROMBECTOMY WAS PERFORMED AT ANOTHER HOSPITAL WITH A DIFFERENT PHYSICIAN. AN ANGIOGRAM SHOWED THE SUBJECT DEVICE WAS OCCLUDED. PATIENT STOPPED TAKING THEIR DUAL ANTIPLATELET MEDICATIONS SINCE BEING DISCHARGED ON (B)(6) 2025 RESULTING IN THE FORMATION OF THROMBUS THROUGHOUT THE ENTIRE SUBJECT DEVICE AND THE THROMBECTOMY. BASED ON THE PHYSICIAN¿S OPINION STATED THAT THE REPORTED EVENT DUE TO THE LACK OF DUAL ANTIPLATELET THERAPY CAUSING CLOT FORMATION WITHIN THE SUBJECT DEVICE. THE PATIENT IS ALIVE WITH DEFICITS AND IS STILL IN HOSPITAL BEING MEDICALLY MANAGED FOR HYDROCEPHALUS.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22728278 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT STENT WAS SUCCESSFULLY DEPLOYED INTO THE PATIENT¿S LEFT INTERNAL CAROTID ARTERY (ICA) WITH MINIMAL MANIPULATION AND NO POST-DEPLOYMENT PROCESSING NEEDED. HOWEVER, A FEW MINUTES AFTER DEPLOYMENT, A CLOT DEVELOPED AT THE DISTAL END OF THE STENT, OBSTRUCTING FLOW INTO THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS RESPONSIVE TO DUAL ANTIPLATELET THERAPY (DAPT) WITH BRILINTA AND HAD NO KNOWN METAL ALLERGIES. TO RESOLVE THE OCCLUSION, THE PATIENT WAS ADMINISTERED A BOLUS DOSE AND PLACED ON A CONTINUOUS INFUSION OF EITHER AGGRASTAT OR INTEGRILIN, WHICH SUCCESSFULLY DISSOLVED THE CLOT AND RESTORED BLOOD FLOW WITHIN 30 MINUTES. THERE WAS A 35 MINUTE PROCEDURAL DELAY. THE PATIENT¿S CONDITION IMPROVED AND WAS DISCHARGED FROM THE HOSPITAL THREE DAYS AFTER THE PROCEDURE, WITH NO SIGNS OF NEUROLOGICAL DEFICITS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21778842 ↗