NC Euphora™ NCEUP37520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169396265), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Burst Container or Vessel; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem; Burst Container or Vessel; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX BALLOON CATHETER, BALLOON INFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON BURST DURING INFLATION. IT WAS ALSO REPORTED THAT IT WAS A STRUGGLE TO DELIVER THE BALLOON. A PRESSURE OF 12 ATM WAS APPLIED HOWEVER THE BALLOON FAILED TO REACH 12 ATM AS IT KEPT LOSING PRESSURE. THE BALLOON WAS NOT FULLY INFLATING. THE BALLOON RUPTURED AND THEY WERE VERY PRE-OCCUPIED WITH FLUSHING THE CATHETER. THE LESION BEING TREATED WAS NON TORTUOUS, HAD CHRONIC TOTAL OCCLUSION OF 100% AND WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693031 ↗