NC Euphora™ NCEUP37515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169396272), received between Aug 10, 2017 and Feb 25, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Deflation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON CATHETER, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS INFLATED TO 8-10ATM IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND COULD NOT BE DEFLATED. THE BALLOON WAS DISCONNECTED FROM THE SYRINGE AND THE BALLOON WAS REMOVED FROM THE PATIENT THROUGH THE GUIDE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442616 ↗
• InjuryFeb 9, 2026Deflation Problem

  IT WAS REPORTED THAT DURING A COMPLEX PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WITH LITHOTRIPSY, ONE NC EUPHORA CORONARY BALLOON FAILED TO DEFLATE AS EXPECTED. THE PATIENT REQUIRED HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291096 ↗
• InjuryMar 31, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE AN NC EUPHORA BALLOON CATHETER IN A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 NOT USED DURING DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AFTER POST DILATION OF A STENT. THE DEFLATION DIFFICULTIES OCCURRED FOLLOWING THE FIRST INFLATION. SEVERAL TECHNIQUES WERE MADE TO DEFLATE THE BALLOON INCLUDING CHANGING THE INFLATION DEVICE AND ATTEMPTS TO BURST THE BALLOON WITH NO SUCCESS. WITH SLIGHT PRESSURE COMING OFF THE BALLOON, IT WAS POSSIBLE TO PULL THE BALLOON OUT OF THE STENT, WHILE PARTIALLY INFLATED, BACK THROUGH THE LAD, THROUGH THE LM AND INTO THE GUIDE CATHETER. THE WHOLE SYSTEM WAS REMOVED TOGETHER VIA THE RADIAL ARTERY. POST ANGIOGRAM SHOWED A DISSECTION IN THE LEFT MAIN. AN ADDITIONAL SENT WAS USED TO TREAT THE DISSECTION. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 13962612 ↗
• InjuryAug 10, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN NC EUPHORA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL LAD. THE PATIENT HAS A KNOWN HISTORY OF CAD. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES.THE LESION WAS PRE-DILATED. DURING ADVANCEMENT THROUGH THE GUIDE CATHETER THE DEVICE FRACTURED. BALLOON HAD PREVIOUSLY BEEN USED TO POST DILATE. STENT NEEDED FURTHER POST DILATION, SO BALLOON WAS LOADED ON GUIDEWIRE, ADVANCEMENT WAS ATTEMPTED BUT IT WAS NOTED THAT THE PHYSICIAN COULDN¿T SEE DISTAL BALLOON ADVANCING UNDER FLUORO DESPITE PROXIMAL SHAFT BEING ADVANCED. WHEN THE PHYSICIAN LOOKED IN THE GUIDE CATHETER, IT WAS SEEN THAT THERE WAS NO ADVANCEMENT OF THE DISTAL DESPITE ADVANCING PROXIMAL SHAFT. PULLED NEGATIVE AND NOTED BLOOD RUSHING BACK INTO INFLATION DEVICE. ATTEMPTED WITHDRAWAL AND PROXIMAL SHAFT CAME OUT OF GUIDE AND DISTAL PORTION REMAINED IN GUIDE CATHETER. IT IS REPORTED THAT THE DEVICE FRACTURED WITHIN GUIDE CATHETER. THE DETACHMENT OCCURRED NEAR THE MIDDLE OF THE SHAFT. A 2.5X15 SC EUPH

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6783863 ↗