NC Euphora™ NCEUP3027XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169395831), received between May 28, 2018 and Nov 11, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Inflation Problem; Improper or Incorrect Procedure or Method; Material Deformation; Inflation Problem; Improper or Incorrect Procedure or Method; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION LOCATED WITH 70% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED DURING BALLOON INFLATION. THE BALLOON WAS INITIALLY USED, INFLATED TO NOMINAL PRESSURE, AND THEN REMOVED TO PERFORM INTRAVASCULAR ULTRASOUND (IVUS). THEN THE BALLOON WAS RE-INSERTED AND INFLATED TO 25 ATM, AND AFTER THE THIRD INFLATION THE BALLOON STARTED GROWING PROXIMALLY BEYOND THE PROXIMAL MARKER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651750 ↗
• InjuryMay 28, 2018Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  AN NC EUPHORA BALLOON CATHETER WAS BEING USED TO POST DILATE A STENT THAT WAS IMPLANTED IN A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 95% STENOSIS IN THE DISTAL CIRCUMFLEX. THERE WAS NO ABNORMALITY IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP. NO ISSUES NOTED WHEN REMOVING THE PROTECTIVE SHEATH OR REMOVING THE STYLETTE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT IS INDICATED THAT THE BALLOON MAY NOT HAVE BEEN FLUSHED THROUGH THE HOOP OR PLACED IN A BOWL OF SALINE PRIOR TO USE. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. SIXTY SALINE/40 CONTRAST WAS USED. NO ISSUES WERE NOTED DURING INFLATION. IT IS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE AFTER FIRST INFLATION. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. FIRST THE PHYSICIAN TRIED TO PULL NEGATIVE PRESSURE WITH A LARGER SYRINGE WITHOUT SUCCESS. THEN THE PHYSICIAN RE-INFLATED THE BALLOON AND PULLED NEGAT

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7547761 ↗