Surpass Elite FDSE45015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327582888), received between Dec 12, 2025 and Mar 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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.

• InjuryMar 30, 2026Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHYSICIAN NOTICED SOME RIBBONING AROUND THE GENU AND WERE ABLE TO WORK OUT THE RIBBON AFTER AWHILE WHICH LED THE PHYSICIAN TO FEEL COMFORTABLE TO DEPLOY THE SUBJECT STENT. ONCE DEPLOYED, THE PHYSICIAN NOTICED THE SUBJECT STENT DID NOT OPEN MUCH MORE THAN IT SHOWED AROUND THE ANTERIOR GENU. THE SUBJECT STENT WAS TWISTED/TORQUED. ONCE THE PHYSICIAN WAS ABLE TO GET THROUGH THE TWISTED PART OF THE SUBJECT STENT, THE PHYSICIAN DECIDED TO DEPLOY A RETRIEVER AND WAS ABLE TO OPEN THE DEVICE ENOUGH TO HELP GET A BALLOON CATHETER THROUGH. THE PHYSICIAN THEN INFLATED THE BALLOON AND THE STENT FINALLY OPENED. THERE WAS SURGICAL DELAY OF 1.5HRS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728842 ↗
• InjuryDec 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, AFTER DEPLOYMENT OF THE STENT THE PROXIMAL SECTION OF THE STENT FISH MOUTHED. THE PHYSICIAN USED DIFFERENT TECHNIQUES USING BALLOON, MICROCATHETER TO OPEN THE STENT, HOWEVER ENDED UP BY IMPLANTING ANOTHER SNARE STENT TO OPEN THE PROXIMAL SECTION OF THE SUBJECT STENT. THE PHYSICIAN REPORTED FORMATION OF CLOT NEAR THE STENT THUS ADDITIONAL MEDICATIONS WERE PROVIDED TO THE PATIENT. THE PROCEDURE WAS DELAYED FOR SEVERAL HOURS, AND THE PATIENT WAS KEPT ON ADDITIONAL RADIATION TIME. THE PROCEDURE WAS REPORTED TO BE COMPLETED, AND THE PATIENT WAS REPORTED TO BE WELL.

  Patient problems: Thrombosis/Thrombus; Unintended Radiation Exposure

  MAUDE report 23790429 ↗