NC Euphora™ NCEUP37512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169396289), received between Jun 8, 2023 and Mar 12, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionMar 12, 2024Deflation Problem; Entrapment of Device; Inflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Entrapment of Device; Inflation Problem; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION 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. THE BALLOON WAS BEING USED TO POST DILATE A STENT. IT WAS REPORTED THAT THERE WAS BALLOON DEFLATION DIFFICULTIES, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS NOTED THAT THE INFLATION WAS NOT UNIFORM, AND PART OF THE BALLOON WOULD NOT INFLATE. THERE WAS THEN DIFFICULTY REMOVING THE DEVICE FOLLOWING STENT DEPLOYMENT. THE INFLATED BALLOON WAS PULLED BACK TO THE TIP OF THE GUIDE, AND EVERYTHING WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884370 ↗
• MalfunctionJun 8, 2023Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE WAS EXPIRED 2 WEEKS WHEN IT WAS USED INSIDE THE PATIENT BODY. NO HARM CAME TO THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084853 ↗