Surpass Elite FDSE32512Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327582598), received between Apr 15, 2025 and Apr 6, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Difficult to Remove

  IT WAS REPORTED THAT WHEN TRYING TO DEPLOY THE SUBJECT STENT, IT WOULD NOT RE-SHEATH. THE SUBJECT STENT WAS STUCK AND WOULDN'T RECAPTURE SO THE SYSTEM WAS REMOVED. THE SUBJECT DEVICE WAS REPLACED WITH AN ALTERNATIVE DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791428 ↗
• MalfunctionDec 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT ENCOUNTERED FRICTION WHEN ATTEMPTING TO RE-SHEATH WITH MICROCATHETER. PHYSICIAN WAS NOT ABLE TO RE-SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843249 ↗
• InjuryNov 24, 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 IMPLANTED ON (B)(6) 2025. APPROXIMATELY 7 DAYS POST PROCEDURE IT WAS REPORTED THAT THE SUBJECT STENT WAS OCCLUDED. A POST OPERATIVE THROMBECTOMY WAS PERFORMED (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23633147 ↗
• MalfunctionApr 15, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT STENT HAD APPOSITION ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21845718 ↗