NC Euphora™ NCEUP3512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169396340), received between Mar 14, 2017 and Apr 1, 2025 — classified as 2 deaths, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE NC EUPHORA CORONARY BALLOON CATHETER HAD BALLOON DEFLATION DIFFICULTIES AND WOULD NOT DEFLATE AT THE LESION SITE. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND IN THE OSTIUM OF LEFT MAIN (LM) CORONARY ARTERY/LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS DETAILED THAT THE BALLOON WOULD NOT DEFLATE IN THE LM. ULTIMATELY THE BALLOON HAD TO BE PULLED OUT WHILE INFLATED. THE BALLOON CAME BACK INTO THE AORTA WHERE AN ATTEMPT WAS MADE TO RE-SHEATH THE DEVICE INSIDE THE GUIDE CATHETER HOWEVER THE BALLOON WOULD NOT FIT. THE BALLOON WAS THEN PULLED BACK INSIDE THE SHEATH AT THE GROIN. THE BALLOON WAS NEVER DEFLATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737899 ↗
• InjuryJun 25, 2024Entrapment of Device; Difficult to Remove; Material Deformation; Entrapment of Device; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON TO TREAT A SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 REMOVAL DIFFICULTIES WERE ENCOUNTERED. THERE WAS DIFFICULTY REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. THE BALLOON GOT STUCK IN CALCIUM AFTER INFLATION, AFTER PERFORMING NON-MEDTRONIC ATHERECTOMY OF THE HEAVY CALCIFIED ARTERY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604192 ↗
• 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 18947830 ↗
• InjuryJan 26, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA PTCA BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE DETACHED/FRACTURED AT THE CATHETER. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. ANOTHER BALLOON WAS USED TO TRAP THE CATHETER IN THE GUIDE AND EVERYTHING WAS REMOVED WITH NO DAMAGE TO THE VESSEL. IT WAS INDICATED THAT THE CATHETER/DELIVERY SYSTEM DEFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11229819 ↗
• DeathSep 4, 2018Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE PATIENT HAD PREVIOUS PCI WITH IMPLANTATION OF A NON-MEDTRONIC DRUG ELUTING STENT. DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE LM ARTERY. THE NC EUPHORA WAS BEING USED FOR POST-DILATION. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED. NEGATIVE PREP WAS PERFORMED. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON DETACHED FROM THE SHAFT IN THE DISTAL LM TO LAD DURING REMOVAL. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE PATIENT WAS STABLE. THE PATIENT HAD SURGERY AND ALL OF THE BALLOON WAS RECAPTURED FROM THE BODY. IT WAS REPORTED THAT THE PATIENT EXPIRED IN RECOVERY 5 DAYS POST INDEX PROCEDURE, ON THE (B)(6) 2018. THERE IS NO CAUSE OF DEATH AVAILABLE AT THIS TIME. THERE WAS NO EVIDENCE OF RESTENOSIS OR THROMBUS. THE VESSEL WAS PATENT, VISIBLE. THE PATIENT WAS ON

  Patient problems: Death

  MAUDE report 7843845 ↗
• InjuryMay 29, 2017Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT A NON-CALCIFIED AND NON-TORTUOUS PROXIMAL LAD LESION EXHIBITING 80% STENOSIS. IT WAS REPORTED THAT A NC EUPHORIA BALLOON WAS SELECTED. DAMAGE WAS NOTED TO THE OUTER CARTON. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. ISSUES WERE ENCOUNTERED REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THE STYLET WAS DIFFICULT TO REMOVE BUT CAME OUT WITH NO NOTICEABLE DAMAGE TO THE BALLOON. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING DELIVERY THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE OR EXCESSIVE FORCE USED. THE BALLOON DID NOT INFLATE AND DYE WAS SEEN STREAMING INTO THE CX ARTERY. THE PHYSICIAN PULLED NEGATIVE ON THE INFLATION DEVICE AND NO BLOOD WAS PRESENT IN THE INDEFLATOR. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON BUT ONLY THE BACK SHAFT OF THE CATHETER CAME OUT. THE BALLOON REMAINED IN THE PROXIMAL LAD. THE PHYSICIAN ADVANCED A NON-MDT WIRE INTO THE GUIDE CATHETER AND POSITIONED THE TIP IN THE DISTAL 1/3 OF THE GUIDE. A NON-MDT CATHETER WAS USED OVER THE INSERTED WIRE AND WAS INFLATED T

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6596424 ↗
• InjuryMar 14, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE AN NC EUPHORA BALLOON TO TREAT A LESION IN THE RCA. NO DAMAGE NOTED TO PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT IS REPORTED THAT A BALLOON BURST/LEAK OCCURRED DURING THE FIRST BALLOON INFLATION TO 30 ATMS. DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS ALSO REPORTED THAT A THE CATHETER DETACHED DURING REMOVAL. THE DETACHED PORTION REMAINS IN VIVO. AN UNSUCCESSFUL ATTEMPT WAS MADE TO SNARE THE DETACHED PORTION. THE DEVICE WAS SUBSEQUENTLY REMOVED IN THE OPERATING ROOM. PATIENT IS ALIVE WITH INJURY, PATIENT WENT IN FOR OPEN HEART SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6401956 ↗