NC Euphora™ NCEUP2512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169395930), received between Aug 31, 2017 and Sep 25, 2026 — classified as 1 injury, 5 malfunctions.

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

• InjurySep 25, 2026Deflation Problem

  It was reported that during a procedure involving one NC Euphora balloon catheter deflation difficulties were encountered. The device would not deflate at the lesion site. The lesion being treated was a severely calcified, moderately tortuous lesion with 99% stenosis in the mid Circumflex (CX) Artery. The device was inspected prior to use with no issues noted. 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 and excessive force was not used during delivery. During pre-dilation of the severe mid CX lesion with severe calcification, the balloon would not deflate. After several attempts of deflation with a suction syringe, the balloon was removed through the guide and sheath. Rewiring was done and the PCI was completed. No further patient complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896651 ↗
• MalfunctionFeb 23, 2021Detachment of Device or Device Component; 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 LESION. IT WAS REPORTED THAT THE DEVICE DETACHED / CRACKED DURING THE PROCEDURE. IT WAS STATED THAT THE DETACHED PORTION OF THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365326 ↗
• MalfunctionDec 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AN NC EUPHORA RX PTCA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL CX ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCES WAS NOT USED. IT WAS REPORTED THAT THE SHAFT BROKE OUTSIDE THE BODY AND THAT THE PHYSICIAN WAS ABLE TO GRASP THE DISTAL PORTION OF THE BROKEN SHAFT AND REMOVE IT FROM THE BODY WITHOUT INJURY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9494347 ↗
• MalfunctionJun 12, 2019Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  AN NC EUPHORA RX PTCA BALLOON CATHETER WAS USED TO POST-DILATE A NONE TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. KISSING BALLOON WAS PERFORMED POST STENTING IN THE BIFURCATION LAD/DIAGONAL. IT WAS REPORTED THAT AFTER THE BALLOON WAS INFLATED TO 10ATM IT WOULD NOT DEFLATE AT THE LESION SITE. DEFLATION WAS ATTEMPTED WITH MULTIPLE NEGATIVES. THE BALLOON WAS REMOVED WHILE IT WAS INFLATED BY PULLING WITH SOME FORCE. IT WAS INDICATED THAT THE YELLOW TIP SECTION OF THE INNER IS MISSING. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Vascular Dissection

  MAUDE report 8690452 ↗
• MalfunctionMay 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AN NC EUPHORA WAS INTENDED TO BE USED DURING A PROCEDURE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUE NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 IS REPORTED THAT THE BALLOON HAD JUST STARTED TO BE INSERTED WHEN THE SHAFT BROKE/DETACHED, DURING DELIVERY THROUGH THE VESSEL. THE DEVICE WAS PULLED OUT. NO PART OF THE DEVICE REMAINED IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8602815 ↗
• MalfunctionAug 31, 2017Leak/Splash; Leak/Splash

  PHYSICIAN INTENDED TO USE AN NC EUPHORA BALLOON CATHETER TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE DISTAL CIRCUMFLEX WITH 100% CHRONIC TOTAL OCCLUSION. THERE WAS AN ANATOMICAL ABNORMALITY IN THAT THE ORIGIN OF THE CIRCUMFLEX IS FROM THE RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THERE WAS NO DAMAGE NOTED TO PACKAGING AND THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE LESION WAS PREDILATED AND THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN OBSERVED THAT THERE WAS RESISTANCE AND EXCESSIVE FORCE WAS NOT USED. WHEN THE BALLOON WAS INFLATED AT 16ATM THERE WAS BALLOON BURST, LEAK OR CATHETER LEAK . THE DEVICE WAS MOVED/REPOSITIONED IN THE LESION PRIOR TO THE BURST AND THE BURST OCCURRED ON A SUBSEQUENT INFLATION. WHILE THE BALLOON WAS INFLATING, BLOOD WAS OBSERVED. THE STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6833494 ↗