NC Euphora™ NCEUP4512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169396173), received between Feb 17, 2020 and Sep 23, 2026 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  It was reported that during a procedure involving one NC Euphora coronary balloon, a balloon rupture occurred during balloon inflation. The lesion being treated was non tortuous, non calcified with 90% stenosis in the proximal Right Coronary Artery (RCA). The device was inspected before use 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. The NC Euphora balloon was inflated once at 14ATM for 10 seconds in the proximal RCA lesion for post dilation of the stent when it ruptured. The NC Euhpora was pulled back into the right radial artery for removal. However difficulties were encountered removing the device. The device would not fit through the 6F radial sheath. It was attempted to pull the wire and guide out with balloon/catheter inside. However, the distal end/balloon tip of the NC Euphora balloon then fractured off and became dislodged in the patients radial artery. As a result, the patient was sent to vascular surgery for removal and further vessel injury. The detached part of the device was successfully removed. The

  Patient problems: Insufficient Information

  MAUDE report 50867418 ↗
• InjuryOct 25, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE PROXIMAL 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 DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. DEFLATION ISSUES OCCURRED DURING SUBSEQUENT INFLATION. AN ATTEMPT WAS MADE TO POP THE BALLOON WITH A SCORING BALLOON BUT FAILED. THE BALLOON WAS THEN PULLED BACK TO THE OSTIUM OF THE GUIDE AND THEN PULLED THE WIRE, BALLOON AND GUIDE BACK INTO THE RIGHT RADIAL ARTERY SHEATH FOR REMOVAL. HOWEVER, THE BALLOON COULD NOT BE REMOVED. IT WAS ALSO REPORTED THAT THE DEVICE DETACHED DURING ATTEMPTED REMOVAL. A VASCULAR SURGEON WAS CALLED TO PERFORM A CUT-DOWN PROCEDURE OF THE RIGHT RADIAL ARTERY, WHICH WAS SUCCESSFULLY DONE, AND THE BALLOON WAS REMOVED. THE DETACHED PORTION OF THE BALLOON WAS RE

  Patient problems: Insufficient Information

  MAUDE report 20532873 ↗
• MalfunctionMay 9, 2024Deflation Problem; Device Dislodged or Dislocated; Material Deformation; Deflation Problem; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A NON-CALCIFIED, SOFT LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PROCEDURE WAS FOR AN ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE BALLOON WAS BEING USED TO POST DILATE A STENT. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE NC EUPHORA WAS BLOCKING FLOW IN THE ARTERY. THE DEVICE WAS TAKEN TO THE GUIDE AND THEN EVERYTHING WAS PULLED OUT OF THE ARTERY TOGETHER. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED, AND THE STENT WAS POST DILATED WITH ANOTHER 4.5X12MM NC EUPHORA BALLOON TO 12 ATM. THE PATIENT IS ALIVE WITH NO FURTHER INJURY AND IS UNHARMED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19277775 ↗
• InjuryJan 4, 2023Burst Container or Vessel; Inflation Problem; Detachment of Device or Device Component; Burst Container or Vessel; Inflation Problem; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA PTCA BALLOON CATHETER TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), VIA A TRANSRADIAL APPROACH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS BEING USED TO POST-DILATED A DEPLOYED STENT. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. WHEN AN ATTEMPT WAS MADE TO INFLATE THE BALLOON THERE WAS NO RESISTANCE. A BALLOON BURST WAS ENCOUNTERED AT NOMINAL PRESSURE AND THE BALLOON SEPARATED FROM CATHETER SHAFT. WHEN THE DEVICE WAS WITHDRAWN FOR INSPECTION IT WAS NOTED THAT THE BALLOON HAD 'BROKEN OFF' AND ONLY THE BALLOON CATHETER CAME BACK. THE BALLOON WAS LOCATED VIA THE MARKER BANDS. AN ATTEMPT WAS MADE TO SNARE THE BALLOON BUT THE BALLOON LODGED IN THE WRIST. THE VASCULAR SURGEON WAS CALLED. THE PATIENT IS DESCRIBED AS OK AND NO FURTHER INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 16093348 ↗
• MalfunctionFeb 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A NC EUPHORIA PTCA BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT THE BALLOON CATHETER SNAPPED IN HALF AS IT WAS GOING INTO THE PATIENTS BODY. THE DEVICE WAS REMOVED WITHOUT COMPLICATIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9715878 ↗