NC Euphora™ NCEUP2515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169396159), received between Apr 27, 2017 and Sep 15, 2022 — classified as 2 injuries, 6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Fracture; Detachment of Device or Device Component; Fracture; 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. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT 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 DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE DETACHED, CRACKED, OR FRACTURED AT THE CATHETER DURING DELIVERY THROUGH THE VESSEL. THE DETACHED PORTION DOES NOT REMAIN IN THE PATIENT. THE DEVICE WAS REMOVED BY PULLING ALL THE SYSTEM OUT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15425819 ↗
• InjuryNov 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE NC EUPHORA RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A NON-CALCIFIED LESION. 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 PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED DURING DELIVERY THROUGH THE VESSEL. THE DETACHED PORTION WAS REMOVED FROM THE PATIENT USING A SNARE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10911197 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE R-PDA. FIVE NC EUPHORA AND ONE SPRINTER LEGEND PTCA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT PATIENT'S CARDIAC ENZYMES WERE ELEVATED ON THE SAME DAY POST INDEX PROCEDURE. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 10867135 ↗
• MalfunctionJan 9, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A NC EUPHORA RX PTCA BALLOON CATHETER. THE DEVICE WAS INSPECTED 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 REPORTED THAT DURING INITIAL INFLATION THAT THE BALLOON WAS NOT HOLDING PRESSURE, A LEAK WAS NOTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9568252 ↗
• MalfunctionNov 15, 2018Leak/Splash; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE NC-EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT 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 REPORTED THAT A BALLOON LEAK OCCURRED ON THE FIRST INFLATION WHILE INFLATING TO 12ATM. IT IS INDICATED THAT THERE WAS A HOLE IN THE BALLOON PRIOR TO INFLATING THE DEVICE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8072909 ↗
• MalfunctionJan 10, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE TWO NC EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY FOR THE FIRST DEVICE (LOT NO:213084941). THE DEVICES WERE INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICES WERE BEING USED TO PRE-DILATE THE LESION. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BOTH BALLOONS BURST DURING BALLOON INFLATION AT 17 ATM¿S. THE DEVICES WERE NOT MOVED OR REPOSITIONED PRIOR TO THE BURST. THERE WAS NO SUDDEN OR GRADUAL PRESSURE DROP NOTED ON THE INFLATION DEVICE. THE BURSTS OCCURRED DURING THE FIRST INFLATION. THE LESION WAS TREATED WITH ORBITAL ATHERECTOMY PRIOR TO BALLOON ANGIOPLASTY WITH THE TWO NC EUPHORA BALLOONS THE PHYSICIAN COMPLETED THE PROCEDURE BY USING ORBITAL ATHERECTOMY WITH NON MDT DEVICE AND ANGIOPLASTY PR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7177747 ↗
• MalfunctionJan 10, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE TWO NC EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY FOR THE FIRST DEVICE (LOT NO:213084941). THE DEVICES WERE INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICES WERE BEING USED TO PRE-DILATE THE LESION. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BOTH BALLOONS BURST DURING BALLOON INFLATION AT 17 ATM¿S. THE DEVICES WERE NOT MOVED OR REPOSITIONED PRIOR TO THE BURST. THERE WAS NO SUDDEN OR GRADUAL PRESSURE DROP NOTED ON THE INFLATION DEVICE. THE BURSTS OCCURRED DURING THE FIRST INFLATION. THE LESION WAS TREATED WITH ORBITAL ATHERECTOMY PRIOR TO BALLOON ANGIOPLASTY WITH THE TWO NC EUPHORA BALLOONS THE PHYSICIAN COMPLETED THE PROCEDURE BY USING ORBITAL ATHERECTOMY WITH NON MDT DEVICE AND ANGIOPLASTY PR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7177741 ↗
• MalfunctionApr 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A NC EUPHORA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY WHICH WAS REPORTED TO HAVE NO CALCIFICATION BUT MILDLY TORTUOUS WITH 80% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE ENCOUNTERED 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. IT WAS REPORTED THE SHAFT OF THE BALLOON BROKE DURING INSERTION INTO THE GUIDE CATHETER. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525226 ↗