NC Euphora™ NCEUP27506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169396128), received between Nov 4, 2020 and Nov 4, 2020 — classified as 1 death.

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.

• DeathNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE 2ND OBTUSE MARGINAL. TWO DAYS LATER DURING A STAGED PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED; TWO IN THE RAMUS AND ONE IN THE LCMA. ONE NC EUPHORA BALLOON CATHETER WAS ALSO USED STAGED PROCEDURE. APPROXIMATELY 20 MONTHS LATER THE PATIENT SUFFERED CARDIOGENIC SHOCK, SEVERE MITRAL REGURGITATION, WORSENING RENAL FAILURE AND DIED. DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY COMMENTED "DEATH." CEC ADJUDICATED THE DEATH AS A CARDIAC DEATH

  Patient problems: Death

  MAUDE report 10783697 ↗