NC Euphora™ NCEUP3515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169396333), received between Feb 13, 2018 and Dec 20, 2023 — classified as 2 deaths, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• DeathDec 20, 2023Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING BALLOON INFLATION. THE BALLOON HAD BEEN INFLATED TO 10 ATM FOR 15 SECONDS, 14 ATM FOR 20 SECONDS AND 18 ATM FOR 20 SECONDS PRIOR TO THE RUPTURE. THE BALLOON DEFLATED UPON RUPTURE AND COULD NOT BE ADVANCED OR WITHDRAWN. AN EFFORT WAS MADE TO ADVANCE A NON-MEDTRONIC GUIDE EXTENSION CATHETER OVER THE BALLOON SHAFT, BUT THIS WAS UNSUCCESSFUL AS THE DISTAL END OF THE BALLOON CATHETER BROKE OFF AND REMAINED IN THE LAD. THE PATIENT WAS SENT TO SURGERY TO HAVE THE BALLOON MATERIAL AND RADIOPAQUE MARKERS REMOVED. THE PATIENT IS ALIVE AND STILL IN THE HOSPITAL.

  Patient problems: Cardiac Arrest; Device Embedded In Tissue or Plaque; Insufficient Information; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion; Shock; Thrombosis/Thrombus

  MAUDE report 18362060 ↗
• MalfunctionNov 29, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA BALLOON TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT DEVICE CATHETER BROKE DURING DELIVERY THROUGH THE VESSEL. THE DEVICE DID NOT ADVANCE SMOOTHLY AND THERE WAS SLIGHT RESISTANCE. ONCE THE BALLOON REACHED THE TARGET LESION THE INFLATION OF THE BALLOON WAS NOTED TO BE SLOW. IT APPEARED THAT A BALLOON BURST HAD OCCURRED, HOWEVER, THIS WAS NOT SEEN AND COULDN'T BE DETERMINED. WHEN THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER IT WAS NOTICED THAT THE SHAFT WAS BROKEN. THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT. THE DEVICE WAS REMOVED THROUGH NORMAL REMOVAL METHODS, AND ALL PIECES OF THE DEVICE WERE ACCOUNTED FOR WHEN REMOVED FROM THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877106 ↗
• DeathApr 30, 2021Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  THE PATIENT HAD AN EJECTION FRACTION OF LESS THAN 20% PRIOR TO THE PROCEDURE. DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED LESION LOCATED IN THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT, HOWEVER THERE WERE SUBSEQUENT DIFFICULTIES IN THEN RETRACTING BACK THROUGH THE PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. IT WAS ALSO REPORTED THAT THE DEVICE DETACHED AT THE TIP DURING DELIVERY THROUGH THE VESSEL. IT WAS STATED THAT THE DETACHED PORTION OF THE TIP WAS REMOVED FROM THE PATIENT USING A FILTER. IT WAS STATED THAT THE PATIENT HAD CARDIAC ARREST. THE PATIENT WAS REPORTED TO HAVE DECEASED.

  Patient problems: Insufficient Information

  MAUDE report 11751251 ↗
• MalfunctionMar 9, 2020Leak/Splash; Leak/Splash

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE PROXIMAL DIAGONAL BRANCH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. IT WAS REPORTED THAT DURING NEGATIVE PREP, THE BALLOON WAS IN THE PATIENTS BODY AND BLOOD WAS ASPIRATED IN THE INFLATION DEVICE. THE BALLOON HAD NOT BEEN INFLATED. IT WAS STATED THAT THERE WAS A LEAK COMING FROM THE SHAFT OF THE BALLOON. THE BALLOON WAS REMOVED FROM THE PATIENT WHEN THIS WAS OBSERVED. THE BALLOON WAS INFLATED FOLLOWING REMOVAL OF THE DEVICE FROM THE BODY TO IDENTIFY THE SOURCE OF THE LEAK. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9804885 ↗
• MalfunctionMay 30, 2019Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component; Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component

  AN NC EUPHORA RX PTCA BALLOON CATHETER WAS USED TO TREAT A NONE TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE 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 DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION. THE DISTAL SECTION ON THE BALLOON APPEARED TO DEFLATE AND THE PROXIMAL SECTION OF THE BALLOON DID NOT LOOK DEFLATED. AN ATTEMPT WAS MADE TO PULL NEGATIVELY ON THE INFLATION DEVICE AND THEN TRIED A SEPARATE SYRINGE BUT IT STILL MADE NO DIFFERENCE. THE PHYSICIAN PULLED THE BALLOON OUT OF THE BODY WITHOUT MUCH RESISTANCE. THE BALLOON LOOKED PARTIALLY DEFLATED AFTER INSPECTION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8653323 ↗
• MalfunctionFeb 13, 2018Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN NC EUPHORA RX BALLOON CATHETER WAS BEING USED TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO DAMAGE WAS NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT DURING BALLOON INFLATION THE BALLOON BURST/ LEAKED. LOW PRESSURE WAS APPLIED. ZERO INFLATIONS WERE APPLIED TO THE DEVICE PRIOR TO THE ISSUE OCCURRING. 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7265889 ↗