NC Euphora™ NCEUP5012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169396104), received between Mar 21, 2024 and Sep 12, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• InjurySep 12, 2025Entrapment of Device; Deformation Due to Compressive Stress; Device Damaged by Another Device; Entrapment of Device; Deformation Due to Compressive Stress; Device Damaged by Another Device

  DURING THE INITIAL PROCEDURE THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION MANIFESTED BY A SEVERE 90% STENOSIS INVOLVING THE DISTAL LEFT MAIN CORONARY ARTERY EXTENDING INTO THE PROXIMAL SEGMENTS OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX CORONARY ARTERIES. THREE STENTS WERE IMPLANTED: A 3.0 X 15MM ONYX FRONTIER STENT, A 4.0 X 18 MM ONYX FRONTIER STENT, AND A 4.5 X 18MM ONYX FRONTIER STENT IMPLANTED. A 0.014 NON-MEDTRONIC WIRE WAS ADVANCED AND PLACED WITHIN THE DISTAL SEGMENT OF THE LAD. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE 1ST OBTUSE MARGINAL BRANCH. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM PRIMARY ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY EXTENDING INTO THE PROXIMAL LAD. AN IVUS CATHETER WAS THEN ADVANCED AND IVUS ASSESSMENT OF THE LEFT MAIN CORONARY ARTERY AND LAD WAS OBTAINED. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM FURTHER ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY INTO THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. AN ONYX FRONTIER 3 X 15 MM DRUG-ELUTING STENT WAS THEN ADVANCED AND PLACED WITHIN THE PROXIMAL LEFT CIRCUMFLEX CORONARY EXT

  Patient problems: Ischemia

  MAUDE report 23036039 ↗
• 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 BEF ORE THE PATIENT ARRIVED TO THE EMERGENCY ROOM (ER). ADDITIONAL CPR WAS PERFORMED, HOWEVER, THIS WAS UNSUCCESSFUL IN OBTAINING BLOOD PRESSURE. T

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 18947614 ↗