NC Euphora™ NCEUP3520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169396326), received between Jun 10, 2019 and Jan 14, 2026 — classified as 1 death, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathJan 14, 2026Deflation Problem; Entrapment of Device; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON, DEFLATION DIFFICULTIES WERE ENCOUNTERED. DURING THE ELECTIVE OUTPATIENT PROCEDURE, THE PATIENT WAS NOTED TO HAVE PROXIMAL MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH IFR MEASUREMENT OF 0.59, CONSISTENT WITH SIGNIFICANT AND OBSTRUCTIVE CORONARY ARTERY DISEASE. A DECISION WAS MADE TO PREP THE LESION FURTHER WITH INTRAVASCULAR LITHOTRIPSY (IVL). THE IVL WAS PERFORMED WITH 3.0MM BALLOON ACROSS THE PROX-MID LAD WITH GOOD BALLOON EXPANSION. ONE ONYX FRONTIER STENT WAS DEPLOYED WITH GOOD BALLOON EXPANSION. THE 3.5MM NC BALLOON WAS USED TO POST-DILATE THE ONYX FRONTIER STENT. THERE WERE NO ISSUES WHEN ADVANCING THE NC BALLOON DISTAL TO THE STENT. THE STENT WAS INFLATED A FEW MILLIMETERS PROXIMAL TO THE EDGE OF THE DISTAL PORTION OF THE STENT. THE NC BALLOON WAS INFLATED TO 12 ATM. DURING POST STENT DILATIONS, THE 3.5MM NC EUPHORA BALLOON FAILED TO DEFLATE. IT WAS REPORTED THAT THERE WERE NO VISIBLE KINKS ON THE SHAFT OF THE BALLOON DEVICE. DOUBLE NEGATIVE PRESSURE WAS ATTEMPTED ON THE BALLOON, BUT THE BALLOON WOULD NOT DEFLATE AND REMAINED INFLATED. A SECOND INDEFLATOR WAS USED TO ATTEMPT TO DEFLATE TH

  Patient problems: Cardiac Arrest; Device Embedded In Tissue or Plaque; Heart Block; Obstruction/Occlusion; Tachycardia; Ventricular Fibrillation

  MAUDE report 24066518 ↗
• InjuryOct 16, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA CORONARY BALLOON, BALLOON DEFLATION DIFFICULTIES OCCURRED. THE BALLOON FAILED TO DEFLATE IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE PATIENT HAD TO GO TO SURGERY FOR REMOVAL OF THE DEVICE. THE DEVICE WAS STUCK INFLATED. BYPASS WAS PERFORMED. THE TARGET LESION EXHIBITED MODERATE TORTUOSITY AND MODERATE CALCIFICATION WITH 80 TO 85% LONG CALCIFIED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED 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. PATIENT IS DOING WELL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308247 ↗
• MalfunctionApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT CATHETER COMPLETELY BROKE IN HALF. THE PATIENT IS ALIVE WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175598 ↗
• InjuryJul 28, 2023Deflation Problem; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX BALLOON CATHETER TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS 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 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. THE BALLOON WAS BEING USED TO POST DILATE A STENT. IT WAS DETAILED THAT MANY TECHNIQUES WERE ATTEMPTED TO DEFLATE THE DEVICE HOWEVER THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes

  MAUDE report 17412665 ↗
• MalfunctionJul 19, 2022Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). 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 AT THE LESION SITE FOLLOWING INFLATION. IT WAS DETAILED THAT THE BALLOON WAS INFLATED AND DEFLATED MULTIPLE TIMES WITHIN THE VESSEL. ON THE FINAL INFLATION, THE BALLOON WOULD NOT DEFLATE IN THE OSTIUM OF THE RCA. IT WAS STATED THAT AN ATTEMPT WAS MADE TO DISLODGE THE BALLOON AND ADVANCE THE GUIDE CATHETER OVER THE BALLOON HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE IN-DEFLATOR WAS THEN REMOVED AND A SYRINGE ATTACHED, THE BALLOON WOULD STILL NOT DEFLATE. THE GUIDE CATHETER WAS PLACED NEAR THE BALLOON AND EVERYTHING WAS REMOVED TOGETHER THROUGH THE RADIAL ARTERY. NO SURGERY OR INTERVENTION WERE REQUIRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050657 ↗
• MalfunctionJun 15, 2021Deflation Problem; Deflation Problem

  ONE NC EUPHORA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). 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 AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. IT WAS STATED THAT THE PHYSICIAN ATTEMPTED TO BURST THE BALLOON WITH STIFF TIPPED WIRE BUT WAS UNSUCCESSFUL SO THE BALLOON, GUIDE CATHETER AND GUIDE WIRE WERE THEN REMOVED TOGETHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999328 ↗
• MalfunctionJul 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE IT WAS INTENDED TO USE AN NC EUPHORA RX PTCA BALLOON CATHETER WAS BEEN USED TO TREAT A LESION. IT WAS REPORTED THAT THE DEVICE BROKE IN THE GUIDE CATHETER AND FAILED TO CROSS THE LESION. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8758207 ↗
• InjuryJun 10, 2019Deflation Problem; Deflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A NC EUPHORIA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. IT IS INDICATED THAT THE BALLOON WAS INFLATED TO 20ATM TO BURST THE BALLOON AS INTERVENTION. NO OTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 8683144 ↗