NC Euphora™ NCEUP4508XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169396180), received between Dec 9, 2016 and Aug 28, 2024 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON DURING A PROCEDURE IN THE PROXIMAL TO OSTIAL LEFT ANTERIOR DESCENDING LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS 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 A BALLOON BURST/RUPTURE OCCURRED DURING BALLOON INFLATION BELOW THE RATED BURST PRESSURE (RBP). IT WAS ALSO REPORTED THAT THE BALLOON HAD A COMPLETE DISARTICULATION FROM THE WIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091031 ↗
• DeathApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST DIAGONAL AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LCMA. ANOTHER RESOLUTE ONYX DES WAS ALSO IMPLANTED. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM VENTRICULAR TACHYCARDIA AND DIED. EVENT WAS TREATED WITH MEDICATION, CPR AND ICD FIRED SHOCK. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9961702 ↗
• MalfunctionNov 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A 4.50 X 8 MM NC EUPHORA BALLOON AND A COUGAR LS GUIDEWIRE WERE USED TO PERFORM MULTIPLE BIFURCATION STENTING TECHNIQUES IN AN EXPLANTED PORCINE HEART. THE GUIDEWIRE WAS FLUSHED AND EXAMINED BEFORE USE WITH NO ISSUES. THERE WERE NO ISSUES NOTED WHEN LOADING THE BALLOON ONTO THE GUIDEWIRE. IT WAS REPORTED THAT THE NC EUPHORA BALLOON FROZE ON THE COUGAR WIRE AND AFTER EXCESSIVE FORCE APPLIED THE DISTAL ASSEMBLY SEPARATED. IT WAS STATED THAT THE DISTAL ASSEMBLY COMPLETELY DETACHED FROM THE DEVICE. THE BALLOON, WIRE AND DISTAL ASSEMBLY WERE ALL REMOVED. THE PROCEDURE WAS COMPLETED USING NEW DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335096 ↗
• MalfunctionDec 9, 2016Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING AN NC EUPHORA BALLOON TO TREAT A NON- TORTUOUS LESION IN THE LAD. IVUS SHOWED FIBROTIC/CALCIFIC PLAQUE, 80% STENOSIS IN THE PROXIMAL LAD. NO DAMAGE WAS NOTED TO PACKAGING AND THE DEVICE HAD NO ISSUES REPORTED WHEN INSPECTED UPON REMOVAL FROM HOOP. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO ANATOMICAL ABNORMALITIES WERE REPORTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS SUCCESSFULLY INFLATED WITHIN RBP .IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED IN REMOVING THE NC EUPHORA BALLOON (NCEUP4012X). DURING RETRACTION, THE BALLOON WRAPPED AROUND THE WIRE. THE PHYSICIAN THEN ATTEMPTED TO USE ANOTHER NC EUPHORA (NCEUP4508X) BALLOON. NO DAMAGE WAS NOTED TO PACKAGING AND THE DEVICE HAD NO ISSUES REPORTED WHEN INSPECTED UPON REMOVAL FROM HOOP. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT AFTER IT WAS DEFLATED THE BALLOON ALSO WRAPPED AROUND THE WIRE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6157541 ↗