NC Euphora™ NCEUP3012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169395862), received between Jun 12, 2019 and Aug 28, 2024 — classified as 1 death, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Burst Container or Vessel; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORIA CORONARY BALLOON DURING A PROCEDURE TO TREAT A LESION. IT WAS REPORTED THAT A BALLOON BURS T/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 CAUSING THE BALLOON TO EMBOLIZE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Embolism/Embolus; Insufficient Information

  MAUDE report 20090228 ↗
• InjurySep 26, 2023Deflation Problem; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Deflation Problem; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX CATHETER BALLOON TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 99% STENOSIS IN THE MID OBTUSE MARGINAL (OM). UNDER ULTRASOUND GUIDANCE THE RIGHT COMMON FEMORAL ARTERY (CFA) WAS ACCESSED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.5X15MM SEMI COMPLIANT BALLOON. 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 BALLOON DEFLATION DIFFICULTIES OCCURRED FOLLOWING THE FIRST INFLATION. IT WAS DETAILED THAT A 6F EBU 4.5 GUIDE CATHETER WAS DIFFICULT TO ENGAGE THE LEFT MAIN (LM) CORONARY ARTERY AND A NON-MEDTRONIC WIRE AT THE DISTAL OM1. IT WAS NOTED TO BE VERY LIKELY CALCIFIED AND WAS DIFFICULT TO TRAVERSE THE MID-LEFT ANTERIOR DESCENDING (LAD) LESION. IT WAS SUCCESSFULLY COMPLETED. AN ADDITIONAL 0.014 NON-MEDTRONIC WIRE WAS PASS TO THE DISTAL OM1 TO HELP BUDDY WIRE THE CIRCUMFLEX SYSTEM. FOLLOWING PRE-DILATION WITH A SC BALLOON, THERE WAS A BRISK TIMI-3 FLOW DOWN THE OM1. A 2.75X26MM ONYX FRONTIER STENT WAS DEPLOYE

  Patient problems: Insufficient Information

  MAUDE report 17821210 ↗
• InjuryAug 3, 2023Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 95% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT 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. IT WAS REPORTED THAT A BALLOON BURST OCCURRED AT 16 ATM DURING BALLOON INFLATION. IT WAS DETAILED THAT THE BALLOON WAS DELIVERED TO THE SITE OF THE HEAVILY CALCIFIED LESION IN THE PROXIMAL LAD. AFTER THE FIRST INFLATION THE BALLOON RUPTURED AND BECAME CAUGHT, OR HUNG UP AT THE LESION SITE OF INFLATION. THERE WERE REMOVAL DIFFICULTIES AS THE BALLOON APPEARED TO BE CAUGHT ON THE CALCIUM, DESPITE SEVERAL ATTEMPT TO PULL THE CATHETER DELIVERY SYSTEM AND BALLOON BACK INTO THE GUIDE CATHETER. THE PATIENT DECEASED. THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE DEATH ARE REPORTED AS CARDIAC ARREST FROM FLOW DISRUPTION IN THE TARGET VESSEL LAD.

  Patient problems: Cardiac Arrest; Chest Pain; Insufficient Information; Non specific EKG/ECG Changes; Obstruction/Occlusion; Shock; Vascular Dissection

  MAUDE report 17448107 ↗
• DeathJun 8, 2022Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A NC EUPHORA BALLOON CATHETER. THE LESION WAS PRE-DILATED WITH A NON-COMPLIANT BALLOON. A 2.5 X 18MM NON-MDT (MEDTRONIC) STENT WAS THEN IMPLANTED INTO THE LESION. THE NC EUPHORA DEVICE WAS INSERTED INTO THE NON-MDT STENT. AFTER THE BALLOON WAS PLACED INSIDE THE STENT IT WAS INFLATED BUT EITHER THE BALLOON DID NOT INFLATE OR IT COULD NOT BE SEEN UNDER FLUORO. THE TECHNICIAN PULLED NEGATIVE ON THE INFLATION DEVICE AND RE-INFLATED THE BALLOON AND THIS TIME THE BALLOON WAS SEEN TO BE INFLATED UNDER FLUORO. THE BALLOON WAS INFLATED FOR A DIRECTED TIME AND THEN THE INFLATION DEVICE WAS PULLED NEGATIVE TO DEFLATE THE BALLOON. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AND WAS STILL INSIDE THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON WITH DIFFERENT DEVICES, WIRES, CATHETERS, MICRO-CATHETERS AND GUIDES, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. IT WAS ALSO REPORTED THAT AT SOME POINT IN TIME THE ARTERY DISSECTED AND THE SHAFT OF THE NC EUPHORA DEVICE BROKE OFF. AFTER THE SHAFT BROKE THE BALLOON REMAINED INFLATED AND PART OF THE CATHETER WAS LEFT IN THE PATIENT AS WELL AS THE INFLATED BALLOON. A NUMBER OF ATTEMPTS WERE MADE TO PUNCTURE THE BALL

  Patient problems: Cardiac Arrest; Insufficient Information; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 14630685 ↗
• MalfunctionDec 3, 2020Fracture; Detachment of Device or Device Component; Fracture; 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 MILDLY TORTUOUS, SEVERELY 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED OR RESTRAIGHTENED DURING USE. IT WAS REPORTED THAT THE CATHETER FRACTURED DURING DELIVERY THROUGH THE VESSEL. THE DEVICE WAS REMOVED FROM THE PATIENT BY PULLING THE ENTIRE DELIVERY SYSTEM OUT INCLUDING THE WIRE. IT WAS STATED THAT THE BALLOON WAS BEING USED TO POST DILATE A NON-MEDTRONIC STENT. IT WAS STATED THAT ORBITAL ATHERECTOMY WAS COMPLETED BEFORE STENT DEPLOYMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10941949 ↗
• MalfunctionFeb 18, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX 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 CATHETER / DELIVERY SYSTEM DEFORMED AND KINKED WHILE THE DEVICE WAS ADVANCING INTO THE VESSEL/ACROSS THE LESION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9719977 ↗
• MalfunctionJan 9, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A NC EUPHORA RX PTCA BALLOON CATHETER. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST/LEAK OCCURRED DURING THE FIRST INFLATION AT 17-18 ATM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568143 ↗
• MalfunctionJun 12, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER, AN NC EUPHORA RX PTCA BALLOON CATHETER, AND A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, SEVERELY CALCIFIED LESION IN OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED USING A CUTTING BALLOON. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED DURING DELIVERY OF THE NC EUPHORA AND THE RESOLUTE ONYX DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ALL THREE DEVICES. IT WAS REPORTED THAT ALL THREE DEVICES BURST WHEN INFLATED TO 12 ATM. THE RESOLUTE ONYX BURST DURING STENT DEPLOYMENT. ONE INFLATION HAD BEEN APPLIED TO THE RESOLUTE ONYX PRIOR TO THE BURST. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690534 ↗