NC Euphora™ NCEUP32515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169395794), received between Jul 9, 2018 and Mar 6, 2026 — classified as 4 injuries, 3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON CATHETER, THE BALLOON DETACHED IN VIVO DURING REMOVAL. IT WAS UNABLE TO  SUCCESSFULLY RETRIEVE THE DETACHED PORTION OF THE DEVICE. THE PHYSICIAN STENTED ACROSS THE DETACHED PORTION OF THE BALLOON. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24530353 ↗
• MalfunctionJun 30, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA CORONARY BALLOON INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. THE BALLOON INFLATED, BUT IT DID NOT HOLD PRESSURE AT 12 ATM. A DEVICE LEAK OCCURRED. THE ISSUE OCCURRED ON THE FIRST INFLATION. THE DEVICE WAS BEING USED TO POST-DILATE A DEPLOYED STENT. THE LESION BEING TREATED WAS NON-TORTUOUS, NON-CALCIFIED WITH 80% ST ENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP/PURGING PERFORMED ON THE DEVICE PRIOR TO USE WITH NO ISSUES NOTED. 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. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356295 ↗
• InjuryJan 31, 2024Burst Container or Vessel; Deflation Problem; Inflation Problem; Difficult to Remove; Burst Container or Vessel; Deflation Problem; Inflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE 3.25X15MM NC EUPHORA BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 70% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.5X15MM EUPHORA BALLOON CATHETER WITHOUT COMPLICATIONS. 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 INFLATION DIFFICULTIES WERE ENCOUNTERED DURING BALLOON INFLATION. IT WAS NOTED THAT THE BALLOON INFLATED SLOWER THAN EXPECTED AT 12ATM. FOLLOWING THE FIRST INFLATION, THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. A NEW INDEFLATOR WAS OPENED HOWEVER, THE BALLOON WOULD NOT DEFLATE. THE INDEFLATOR WAS REMOVED AND IT WAS ATTEMPTED TO DRAW BACK USING A 12CC SYRINGE HOWEVER, THE BALLOON DID NOT DEFLATE. IT WAS DETAILED THAT THE INFLATED BALLOON WAS THEN MANUALLY PULLED PROXIMALLY TOWARDS THE OSTIUM AND INTO THE AORTA OUTSIDE THE GUIDE. AN ATTEMPT WAS MADE TO PUNCTURE THE BALLOON USING A NON-MEDTRONIC WIRE BUT IT DID NOT PUNCTURE. THE BALLOON WAS INFLATED TO 26ATM FOR A FORCED RUP

  Patient problems: Insufficient Information

  MAUDE report 18619166 ↗
• InjuryOct 23, 2020Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS STATED AFTER TRYING NUMEROUS TIMES TO DEFLATE THE BALLOON WITH THE INFLATOR AND SYRINGES, THE BALLOON HAD TO BE OVERINFLATED AND BURST FOR REMOVAL. TOTAL INFLATION TIME IN THE LAD WAS 5 MINUTES. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10725207 ↗
• MalfunctionOct 16, 2020Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  ONE NC EUPHORA BALLOON CATHETER WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT HARM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10689769 ↗
• MalfunctionAug 14, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DURING A PROCURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST DURING BALLOON INFLATION AT 18 ATMS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10406373 ↗
• InjuryJul 9, 2018Burst Container or Vessel; Deflation Problem; Inflation Problem; Material Rupture; Detachment of Device or Device Component; Burst Container or Vessel; Deflation Problem; Inflation Problem

  THE LESION WAS A NON-TORTUOUS, NON-CALCIFIED CTO IN THE LAD, ONE 3.0X15 RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED WITH NO DIFFICULTIES REPORTED. THE LESION HAD BEEN PRE-DILATED. AN ATTEMPT WAS MADE TO POST DILATE THE STENT WITH AN NC EUPHORA BALLOON. NO DAMAGE HAD BEEN NOTED TO THE NC EUPHORA PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE BALLOON FROM THE HOOP/ TRAY. THERE WERE NO ISSUES REMOVING THE STYLETTE. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE BALLOON, EXCESSIVE FORCE WAS NOT USED. INFLATION DIFFICULTIES WERE EXPERIENCED WITH THE BALLOON, TAKING LONGER THAN EXPECTED TO INFLATE (1 SEC TO GET TO 12 ATMS). THE STENT WAS POST DILATED AND DEFLATION DIFFICULTIES WERE THEN ENCOUNTERED. THE BALLOON WAS RUPTURED BY TAKING THE BALLOON TO HIGH ATMOSPHERE WITH THE INFLATION DEVICE. ON REMOVAL OF THE BALLOON CATHETER AND GUIDE WIRE, PAR T OF THE BALLOON HAD DETACHED AND REMAINED IN THE LEFT MAIN. A SNARE WAS UNSUCCESSFUL IN RETRIEVING THE DETACHED PART OF THE BALLOON. THREE PROCEDURE WIRES WERE INTRODUCED INTO THE PATIENT, TORQUED AND WERE SUCCESSFUL IN CAPTURING AND REMOVING THE DETACHED PART OF THE BALLOON

  Patient problems: No Code Available; Patient Problem/Medical Problem

  MAUDE report 7668996 ↗