NC Euphora™ NCEUP4020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169396203), received between Sep 21, 2018 and Feb 7, 2025 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Burst Container or Vessel; Leak/Splash; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Leak/Splash; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE NC EUPHORA RX CORONARY BALLOON CATHETER BURST/LEAKED AT THE BALLOON DURING BALLOON INFLATION. WHEN ATTEMPTING TO POST-DILATE A STENT THE DEVICE WAS UNABLE TO HOLD PRESSURE. THE ISSUE OCCURRED ON FIRST INFLATION AT 18 ATM. THE LESION BEING TREATED HAD MODERATE TORTUOSITY AND MODERATE CALCIFICATION, WITH 90% LESION STENOSIS AND LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE, AND NEGATIVE PREPARATION WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WITH ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS REMOVED WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330781 ↗
• InjuryJun 14, 2024Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  THE PATIENT WAS UNDERGOING CARDIAC CATHETERIZATION FOR POSSIBLE CONCERNS OF UNSTABLE ANGINA. AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON TO TREAT A LESION WITH SIGNIFICANT DISEASE IN THE 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 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 A BALLOON BURST OCCURRED DURING BALLOON INFLATION TO 14 ATM ON THE FIRST INFLATION. THE BALLOON BECAME ENTRAPPED WITHIN THE VESSEL, AND IT WAS NOTED ON FLUOROSCOPY THAT THERE WAS SOME BALLOON DEFORMATION. IT WAS ALSO REPORTED THAT THE CATHETER BROKE DURING REMOVAL OF THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON REMNANT WITH A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) AND OTHER TYPES OF BALLOONS, BUT THIS DID NOT WORK. IT WAS EVENTUALLY POSSIBLE TO GET A SNARE AROUND THE BROKEN PART OF THE CATHETER AND BALLOON LEFT INSIDE THE DEPLOYED STENT. HOWEVER, IT COULD NOT BE REMOVED WITHOUT RESISTANCE A

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

  MAUDE report 19535752 ↗
• InjuryJun 10, 2024Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA BALLOON CATHETER TO TREAT A NON-TORTUOUS LESION WITH 80% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS PRE-DILATED WITH A NON-MEDTRONIC BALLOON. 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 WAS REPORTED THAT THE BALLOON BURST FOLLOWING INFLATION TO 12, 14 AND 16 ATM. A LAUNCHER EBU 3.5 6FR GUIDE CATHETER WAS USED. A NON-MEDTRONIC STENT WAS IMPLANTED. IT WAS ALSO REPORTED THAT PART OF THE BALLOON WITH THE MARKER BAND APPARENTLY BROKE OFF POST RUPTURE AND BECAME STUCK IN BRACHIOCEPHALIC. IT WAS REMOVED SURGICALLY NEXT DAY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504949 ↗
• MalfunctionNov 15, 2023Burst Container or Vessel; Inflation Problem; Leak/Splash; Material Deformation; Burst Container or Vessel; Inflation Problem; Leak/Splash; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO NC EUPHORA RX BALLOON CATHETERS TO TREAT A LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST OCCURRED WHEN USING BOTH DEVICES. IT WAS DETAILED THAT THE TWO NC EUPHORA BALLOON CATHETERS WERE USED TO POST DILATE A STENT. THE 4.00X8MM NC EUPHORA WAS INFLATED TWICE AT 16 ATM FOR 10SECONDS. THE BALLOON RUPTURED DURING THE SECOND DEFLATION. THE 4.0X20MM NC EUPHORA WAS THEN DILATED WITH TWO INFLATIONS AT 14ATM FOR 15SECONDS AND A THIRD INFLATION AT 14ATM FOR 10SECONDS. THE BALLOON RUPTURE OCCURRED DURING THE THIRD DEFLATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139888 ↗
• MalfunctionSep 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE IN VITRO, THE SHAFT BROKE IN 2 PARTS ABOUT 1/3 OF THE WAY BACK FROM THE BALLOON END OF THE DEVICE. THE DEVICE NEVER ENTERED THE PATIENT¿S BODY. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY. DEVICE RETURNED WITH BLOOD PRESENT AND TIP STUBBED WHICH INDICATES USE IN PATIENT, COULD NOT BE CONFIRMED WITH ACCOUNT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897492 ↗