NC Euphora™ NCEUP5015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169396098), received between Jan 19, 2022 and Jan 19, 2022 — classified as 1 injury.

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.

• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE NC EUPHORA BALLOON CATHETER WERE USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). A TELESCOPE GUIDE EXTENSION CATHETER WAS ALSO USED. THE RESOLUTE ONYX DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE NC EUPHORA DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX BUT EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE NC EUPHORA AND EXCESSIVE FORCE WAS NOT USED. THE RESOLUTE ONYX STENT WAS IMPLANTED AND POST-DILATED USING THE NC EUPHORA. IT WAS REPORTED THAT THERE WAS AN ANEURYSM AND A PERFORATION ON THE SMALL BRANCH COMING OFF THE RCA. PATIENT IS STABLE AND DOING FINE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Aneurysm; Perforation

  MAUDE report 13288031 ↗