NC Euphora™ NCEUP4015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169396210), received between Oct 18, 2017 and Mar 21, 2024 — classified as 1 death, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE LAUNCHER GUIDE CATHETER, ONE EUPHORA BALLOON CATHETER, FIVE NC EUPHORA BALLOON CATHETERS, AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED FROM A SPONTANEOUS MYOCARDIAL INFARCTION (MI) AND CARDIAC ARREST / SUDDEN CARDIAC DEATH. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE, HAD EATEN DINNER AND EVERYTHING WAS NORMAL WHEN SUDDENLY THE PATIENT COLLAPSED ON THE GROUND. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF CHEST PAIN, DIAPHORESIS, NAUSEA, OR VOMITING. ADVANCED LIFE SAVING MEASURES WERE UTILIZED. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND A FAMILY MEMBER TRIED TO DO SOME MOUTH-TO-MOUTH UNTIL THE AMBULANCE ARRIVED. WHEN THE AMBULANCE ARRIVED, THEY DETECTED ELECTROMECHANICAL DISSOCIATION (EMD) AND STARTED CARDIOPULMONARY RESUSCITATION (CPR) FOR 30 MINUTES BEFORE THE PATIENT ARRIVED TO THE EMERGENCY ROOM (ER). ADDITIONAL CPR WAS PERFORMED, HOWEVER, THIS WAS UNSUCCESSFUL IN OBTAINING BLOOD PRESSURE. TH

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 18947778 ↗
• MalfunctionNov 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A VERY TORTUOUS AND CALCIFIED LESION LOCATED IN THE RIGHT CORONARY ARTERY. IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE A STENT IN THE RCA, THE NC EUPHORA'S BALLOON SHAFT BROKE OFF AFTER MULTIPLE INFLATIONS. IT WAS STATED THAT ALL PARTS OF THE BALLOON WERE REMOVED FROM THE RCA AND THE PATIENT USING THE GUIDEWIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10913233 ↗
• MalfunctionOct 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS INTENDED TO USE A NC EUPHORA BALLOON DILATATION CATHETER TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY EXHIBITING 90% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE FIRST POST- DILATION WAS SUCCESSFUL PERFORMED. THE NC EUPHORA NEVER LEFT THE GUIDE IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS ADVANCING THE DEVICE TO PERFORM THE SECOND POST-DILATION, TWO WIRES CROSSED IN THE GUIDE, THE NC EUPHORA CATHETER SHAFT KINKED AND BROKE IN HALF WHILE IN THE GUIDE CATHETER, OUTSIDE OF PATIENT. ALL COMPONENTS WERE SUCCESSFULLY REMOVED FROM THE GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE AND THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6957315 ↗