NC Euphora™ NCEUP4012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169396227), received between Dec 9, 2016 and Apr 9, 2024 — classified as 1 death, 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Burst Container or Vessel; Deflation Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Deflation Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND, THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON COULD NOT BE FULLY DEFLATED. A DETACHMENT OF THE BALLOON FROM THE SHAFT AT THE PROXIMAL JUNCTION OF THE BALLOON ALSO OCCURRED. THE PATIENT REQUIRED EMERGENT TRANSFER TO THE HOSPITAL FOR CORONARY ARTERY BYPASS GRAFT (CABG), AND LATER RECEIVED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT IS STILL IN HOSPITAL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 19069071 ↗
• 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 18947611 ↗
• MalfunctionJul 11, 2022Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID 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 DEFLATION DIFFICULTIES OCCURRED. IT WAS STATED THAT THE DEVICE DID NOT DEFLATE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14974884 ↗
• MalfunctionJun 1, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE A NC EUPHORA RX BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT DURING ADVANCEMENT THROUGH THE GUIDE CATHETER, THE NC EUPHORA DEVICE DETACHED, CRACKED OR FRACTURED. THE CATHETER DELIVERY SYSTEM WAS DEFORMED/KINKED. IT WAS ALSO REPORTED THAT THE DEVICE SNAPPED. IT WAS DETAILED THAT THE ISSUE WAS NOTICED IMMEDIATELY AS THE DEVICE WAS ADVANCING INTO THE PATIENT AND THE ENTIRE DEVICE WAS CAPTURED. IT WAS DETAILED THAT THE DEVICE WAS NOT USED IN THE PATIENT. IT WAS DETAILED THAT MORE FORCE WAS USED WITH NC EUPHORA DEVICES IN THE PAST WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565724 ↗
• InjuryDec 13, 2021Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE A NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY CALCIFIED, NON TORTUOUS LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS BEING USING FOR THE PROXIMAL OPTIMIZATION TECHNIQUE (POT) OF A NON MDT STENT FROM THE LEFT MAIN TO THE LAD. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING FIRST INFLATION AT 18 ATM FOR 10 SEC WHEN INFLATED IN THE PROXIMAL PORTION OF THE STENT. DIFFICULTIES REMOVING THE DEVICE WERE ENCOUNTERED. IT WAS STATED THAT THE RUPTURED BALLOON SEEMED TO BE CAUGHT ON THE STENT STRUTS AT THE DISTAL PORTION OF THE BALLOON OR TIP, PREVENTING THE BALLOON FROM BEING REMOVED. IT WAS ALSO REPORTED THAT THE SHAFT OF THE BALLOON BECAME SEPARATED AT THE HYPOTUBE TRANSITION. THE BALLOON WAS CAPTURED USING A GOOSENECK SNARE. AFTER THE SHAFT WAS REMOVED, THERE WAS NO BLEED BACK WHICH WAS SUGGESTED TO BE DUE TO A C

  Patient problems: Embolism/Embolus; Insufficient Information; Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 12983425 ↗
• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A NC EUPHORA BALLOON. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THE CATHETER WAS DEFORMED WITH A KINK. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS ABLE TO ADVANCE THE BALLOON THROUGH A NON MDT 6FR EXTENSION GUIDE CATHETER AND OVER A NON-MDT WIRE UP TO THE 2ND MARKER BAND, THE BALLOON WAS THEN UNABLE TO ADVANCE ANY LONGER AND THE GUIDE KEPT BACKING OUT OF THE VESSEL. ALL THE DEVICES WERE REMOVED TO GET A NEW GUIDE FOR BETTER ENGAGEMENT AND WHEN EVERYTHING WAS PULLED OUT, THE BALLOON CATHETER WAS NOTED TO BE BROKEN IN TWO. ALL THE DEVICE PARTS REMAINED IN THE GUIDE CATHETER, THEREFORE NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576352 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS USED TO TREAT THE LAD. 26 MONTHS POST INDEX PROCEDURE DURING A REVASCULARISATION PROCEDURE ONE NC EUHPORA BALLOON CATHETER AND ONE RESOLUTE ONYX DES WERE USED AND PLAQUE SHIFT OCCURRED AND WAS TREATED WITH IMPLANT OF A RESOLUTE ONYX DES.

  Patient problems: Occlusion

  MAUDE report 9503725 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE TWO NC EUPHORA BALLOON CATHETERS TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE PROXIMAL-MID DIAGONAL BRANCH OF THE LAD USING THE KISSING BALLOON TECHNIQUE. BOTH DEVICES WERE INSPECTED WITH NO ISSUE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUE. THE LESION WAS PRE-DILATED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF EITHER DEVICE. AN ATTEMPT WAS FIRST MADE TO USE THE 4.0MM BALLOON TO TREAT THE LESION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. THE 4.0MM BALLOON WAS PASSED THROUGH THE GUIDE AND WAS IN THE LAD STENT. AN ATTEMPT WAS THEN MADE TO PASS THE 2.5MM BALLOON HOWEVER RESISTANCE WAS ENCOUNTERED. THE 4.0MM BALLOON WAS PULLED BACK AND EVERYTHING WAS PULLED OUT IN THE GUIDE, HOWEVER IT WAS INDICATED THAT A DETACHMENT OCCURRED AT THE BALLOON DURING REMOVAL. THE DETACHED PORTION OF THE DEVICE WAS REMOVED IN THE GUIDE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296054 ↗
• MalfunctionMar 6, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN NC EUPHORA RX BALLOON CATHETER WAS INTENDED TO BE USED TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES FOUND. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT A NON-MEDTRONIC STENT WAS IMPLANTED IN THE LAD. THE PHYSICIAN TRIED TO ADVANCE THE NC EUPHORA BALLOON TO THE LESION SITE BUT FELT SOME RESISTANCE. IT WAS THEN ATTEMPTED TO PULL THE BALLOON OUT, BUT TENSION WAS FELT WHEN TRYING TO REMOVE THE BALLOON AND THE CATHETER BROKE IN HALF. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DETACHED PORTION OF THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7316566 ↗
• 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 6157539 ↗