NC Euphora™ NCEUP4520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169396081), received between Mar 9, 2020 and Mar 9, 2020 — 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.

• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (DES) AND ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE RESOLUTE ONYX DES WAS IMPLANTED. THERE WAS NO ISSUES NOTED OR OBSERVED DURING DEPLOYMENT OF THE STENT. IT WAS STATED THAT POST DILATION OF THE NC EUPHORA BALLOON AT 18 ATM WITHIN THE RESOLUTE ONYX STENT RESULTED IN A PERFORATION. IT IS UNCLEAR WHETHER THE STENT OR THE BALLOON CAUSED THE PERFORATION. IT WAS INDICATED THAT THE BALLOON AND STENT WERE NOT BELIEVED TO BE THE PRIMARY CAUSE OF THE PERFORATION EVENT. IT WAS INDICATED THAT THE EVENT MAY HAVE BEEN ASSOCIATED WITH THE SIGNIFICANT CALCIUM DEPOSITS WITHIN THE ARTERY. THE PERFORATION WAS TREATED WITH A COVERED CORONARY STENT. THE PATIENT WAS REPORTED TO BE ALI

  Patient problems: Injury; Perforation

  MAUDE report 9804478 ↗