NC Euphora™ NCEUP5008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169396074), received between Aug 26, 2020 and Mar 21, 2022 — classified as 1 injury, 1 malfunction.

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 21, 2022Deflation Problem; Deflation Problem

  ONE NC EUPHORA BALLOON CATHETER WAS ATTEMPTED TO BE USED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838165 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE CX AND A NC EUPHORA PTA BALLOON CATHETER WAS ALSO USED IN THE CX. FOLLOWING DAY, PATIENT SUFFERED TROPONIN ELEVATION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO THE DEVICE AND NOT RELATED TO ANTIPLATELET. CEC ADJUDICATED EVENT AS A NON-Q-WAVE MI OF THE TARGET VESSEL, MEDTRONIC EXTENDED HISTORICAL PERI-PCI. CEC ADJUDICATED STENT THROMBOSIS IN THE CX AS NON-EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 10452865 ↗