NC Euphora™ NCEUP2520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169396142), received between Oct 23, 2017 and Jul 22, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 NOTED THAT 80% SALINE/20% CONTRAST WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. DIFFICULTIES WERE ALSO ENCOUNTERED WHEN REMOVING THE DEVICE FOLLOWING STENT DEPLOYMENT. THE BALLOON WAS CUT AND A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS ADVANCED OVER THE BALLOON TO RETRACT THE DEVICE OUT OF THE BODY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19791356 ↗
• MalfunctionMar 22, 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 RIGHT COMMON FEMORAL ARTERY WITH 75¿99% STENOSIS AND SOME CALCIFICATION. A LEFT COMMON FEMORAL APPROACH WAS USED, AND THE LEFT COMMON FEMORAL ARTERY WAS CANNULATED UNDER ULTRASOUND GUIDANCE. THERE WAS SOME CALCIFICATION. IT WAS DECIDED TO TRY AND OPEN UP THE ANTERIOR TIBIALIS LESION. A 0.014 WIRE THAT WAS IN THE PROFUNDAL WAS DIRECTED DOWN THE SUPERIOR FEMORAL ARTERY (SFA) INTO THE POPLITEAL ACROSS THE TIBIOPERONEAL TRUNK AND INTO THE ANTERIOR TIBIAL WITHOUT DIFFICULTY. A NON-MEDTRONIC PTA BALLOON (3.5 X 40MM) WAS ATTEMPTED TO BE USED, HOWEVER THE NON-MEDTRONIC BALLOON FAILED TO CROSS THE LESION. A 2MM OVER THE WIRE BALLOON WAS THEN ATTEMPTED TO BE USED AND SUCCESSFULLY DILATED THE ¿LID SIDE,¿ BUT THERE WAS RESIDUAL NARROWING AS IT IS A VERY HARD CALCIFIED LESION. FURTHER PREPARATION WITH A MONORAIL BALLOON CATHETER WAS ATTEMPTED, HOWEVER THIS WOULD NOT ADVANCE ACROSS THE LESION. AS IT WAS PULLED BACK IT SEEMED TO FRACTURE. THE FRACTURED BALLOON WAS IN THE 45 CM SHEATH. A 0.035 WIRE WAS ADVANCED A 2MM BALLOON INTO THE AREA OF THE SITE, HOWEVER WHEN SLOWLY PULLING BACK ON THE SHEATH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543809 ↗
• InjuryMay 16, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A NC-EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. 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. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT DURING THE FIRST BALLOON INFLATION AT 12ATM A BALLOON RUPTURE OCCURRED. IT WAS ALSO REPORTED THAT A DETACHMENT OCCURRED AT THE BALLOON DURING REMOVAL OF THE DEVICE. THE DETACHED BALLOON WAS REMOVED FROM THE LEFT MAIN BUT COULD NOT BE RETRACTED INTO THE GUIDE CATHETER. AN ATTEMPT WAS MADE TO USE A 2.5X12MM EUPHORA BALLOON TO TRAP THE BROKEN BALLOON AT THE END OF THE GUIDE, HOWEVER IT WAS INSTEAD PUSHED FORWARD INTO THE LEFT MAIN. THE BROKEN BALLOON WAS THEN WIRED PAST AND A 1.5X12MM EUPHORA BALLOON WAS DELIVERED PAST THE BROKEN BALLOON. THE 1.5X12MM EUPHORA SC BALLOON WAS INFLATED AND THE BROKEN BALLOON WAS PULL ED BACK INT

  Patient problems: Injury; Patient Problem/Medical Problem

  MAUDE report 8615141 ↗
• InjuryApr 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE USE AN NC EUPHORIA BALLOON CATHETER TO PRE-DILATE A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION, WITH 80% PROXIMAL STENOSIS AND 90% DISTAL STENOSIS, IN THE MID-DISTAL LEFT-ANTERIOR DESCENDING ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING EITHER THE OUTER PROTECTIVE SHEATH COVERING THE BALLOON, OR THE STYLETTE. THE BALLOON WAS PREPPED IN THE HOOP TO ACTIVATE THE HYDROPHILIC COATING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. (B)(6) 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 AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. THE BALLOON WOULD NOT INFLATE. IT IS REPORTED THAT A PORTION OF THE CATHETER DETACHED DURING DELIVERY THROUGH THE VESSEL. THE CATHETER WAS COMPLETELY SEPARATED INTO TWO PIECES AT THE SITE OF BALLOON SHAFT FRACTURE. THIS WAS NOTED AS THE BALLOON WAS BEING WITHDRAWN FROM THE PATIENT VIA THE SHEATH AND ONLY THE PROXIMAL SEGMENT CAME OUT. THE REMAINING DISTAL S

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7432115 ↗
• MalfunctionOct 23, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE A NC EUPHORA PTCA BALLOON CATHETER TO TREAT A PATIENT'S CALCIFIED RAMUS LESION. THERE WAS NO DAMAGE NOTED TO PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED AND THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE BALLOON WAS BEING USED TO POST DILATE THE STENT THAT WAS JUST PLACED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST DURING THE FIRST INFLATION AFTER THE PHYSICIAN APPLIED AN INFLATION PRESSURE OF 10 ATM. THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES PRE-OR POST THE INFLATION DIFFICULTIES ENCOUNTERED. THE DEVICE WAS NOT MOVED OR RE-POSITIONED PRIOR TO THE BURST. THERE WAS A SUDDEN DROP IN PRESSURE NOTED ON THE INFLATION DEVICE AND NO BLOOD CAME BACK INTO THE ENDOFLATOR. THE BALLOON WOULD NOT HOLD PRESSURE. NO DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE DEVICE WAS REPLACED BY ANOTHER MANUFACTURER¿S PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6968054 ↗