Surpass Elite FDSE50015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327582970), received between May 13, 2025 and Feb 27, 2026 — classified as 1 injury, 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 18, 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.

• MalfunctionFeb 27, 2026Activation Failure

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED ON (B)(6) 2026 AND THE PATIENT DEVELOPED HEMIPLEGIA ON (B)(6) 2026. AFTER THE PHYSICIAN PERFORMED HEAD COMPUTED TOMOGRAPHIC SCAN, CLOT WAS CONFIRMED TO BE PRESENT WITHIN THE SUBJECT STENT. THUS, MECHANICAL THROMBECTOMY WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED ON 04-FEB-2026 CONFIRMED THAT THERE WAS UNKNOWN SLIPPAGE OF GASTRIC SLEEVE AND THE CLOT FORMATION WAS DUE TO MALABSORPTION OF DUAL ANTI-PLATELET THERAPY (DAPT). SUBSEQUENTLY, INFORMATION RECEIVED ON 18-FEB-2026 CONFIRMED THAT THE SUBJECT STENT FAILED TO OPEN AT THE PROXIMAL END (PROXIMAL LEDGE) AND A BALLOON ANGIOPLASTY WAS PERFORMED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471647 ↗
• InjuryMay 13, 2025Malposition of Device; Activation Failure; Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE IT WAS APPEARED TO BE A CLEAR ¿RIBBON¿ IN THE PROXIMAL MIDSECTION OF THE SUBJECT STENT. THE PHYSICIAN BELIEVED THAT THE SUBJECT STENT FLATTENING WOULD OPEN FINAL UNSHEATHE. HOWEVER, AFTER UNSHEATHING, IT BECAME APPARENT THAT THE SUBJECT STENT WAS TWISTED IN THE MID-STENT SEGMENT, DESPITE FULL APPOSITION AT BOTH THE DISTAL AND PROXIMAL ENDS AND GOOD COVERAGE OVER THE 4MM ANEURYSM NECK. VARIOUS TECHNIQUES WERE ATTEMPTED TO CORRECT THE ISSUE¿INCLUDING CROSSING WITH A WIRE, USE OF A STENT RETRIEVER, AND PROXIMAL BALLOONING¿BUT ALL WERE UNSUCCESSFUL. A BALLOON WAS ALSO USED TO MITIGATE THE CRIMPED/TORQUED SUBJECT DEVICE AND REGAIN ACCESS. THE CASE WAS PROLONGED ABOUT 2 HOURS. GIVEN THE PRESENCE OF GOOD COLLATERAL CIRCULATION AND EXCELLENT FLOW STAGNATION IN THE ANEURYSM, THE PHYSICIAN DECIDED TO LEAVE THE IMPLANT IN PLACE AND PROCEED WITH MONITORING. ACCORDING TO THE PHYSICIAN, THE FLOW DIVERTER FAILED TO OPEN DUE TO SEVERE ANATOMY AND POTENTIAL OVERSIZING OF THE IMPLANT DUE TO THE ONE SEGMENT THAT MEASURED 4.7MM. PATIENT IS CURRENTLY ASYMPTOMATIC BUT WILL REMAIN MONITORED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014313 ↗