NC Euphora™ NCEUP3015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169395855), received between Aug 9, 2017 and Jul 14, 2025 — classified as 7 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA CORONARY BALLOON CATHETER DEFLATION DIFFICULTIES AND A DETACHMENT OCCURRED. THE BALLOON WAS UNABLE TO BE DEFLATED AFTER POST-DILATING A STENT. DIFFICULTIES WERE EXPERIENCED REMOVING THE DEVICE. THE BALLOON DETACHED FROM THE CATHETER DURING REMOVAL. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT WAS SENT FOR BYPASS SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22493272 ↗
• MalfunctionJul 3, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX BALLOON, THE BALLOON WOULD NOT INFLATE COMPLETELY AND WOULD NOT HOLD PRESSURE. IT WAS STATED THAT A BALLOON LEAK OCCURRED WHEN THE DEVICE WAS INSIDE THE PATIENT. THE ISSUE OCCURRED DURING THE FIRST BALLOON INFLATION. THERE WAS PARTIAL INFLATION OF THE BALLOON TO NOMINAL PRESSURE. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, NOR WAS EXCESSIVE FORCE USED DURING DELIVERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THERE WAS NO BLOOD OBSERVED IN THE BALLOON. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY USED WITH OTHER DEVICES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393430 ↗
• InjuryMar 20, 2025Burst Container or Vessel; Deflation Problem; Difficult to Remove; Deformation Due to Compressive Stress; Burst Container or Vessel; Deflation Problem; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA CORONARY BALLOON, THE DEVICE EXPERIENCED BALLOON DEFLATION DIFFICULTIES AND WOULD NOT DEFLATE AT THE LESION SITE. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MODERATELY CALCIFIED WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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 DURING DELIVERY. THE NC EUPHORA WOULD NOT DEFLATE AND WOULD NOT MOVE INSIDE THE STENT. MULTIPLE TECHNIQUES WERE ATTEMPTED TO TRY AND MOVE OR DEFLATE THE BALLOON, BUT THESE EFFORTS WERE UNSUCCESSFUL. ULTIMATELY, THE BALLOON HAD TO BE BURST AS IT WOULD NOT DEFLATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21650618 ↗
• MalfunctionNov 29, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ATTEMPT WAS MADE TO USE A NC EUPHORA RX BALLOON CATHETER TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING BALLOON INFLATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228548 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 RESOLUTE ONYX WERE IMPLANTED IN THE RCA. TWO EUPHORA AND ONE NC EUPHORA PTCA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY ONE DAY POST INDEX PROCEDURE, PATIENT'S CARDIO BIOMARKER WERE ELEVATED. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MI INVOLVING THE RCA. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO ANTIPLATELET MEDICATION BUT POSSIBLY RELATED TO INDEX DEVICE. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 10885350 ↗
• InjuryMay 5, 2020Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component; Burst Container or Vessel; Deflation Problem; 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 LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOON BURST AT 18 ATMS. IT WAS ALSO REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AT THE LESION SITE. THE DEVICE WAS REMOVED FROM THE PATIENT USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury; Vascular Dissection

  MAUDE report 10024911 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX WAS IMPLANTED IN THE LAD AND TWO RESOLUTE ONYX STENTS WERE ALSO IMPLANTED IN THE CX. PLAQUE SHIFT OCCURRED IN THE LAD AND CX INTO THE LCMA WHICH WAS TREATED WITH THE IMPLANTATION OF TWO FURTHER RESOLUTE ONYX STENTS; ONE IN THE LAD AND ANOTHER IN THE CX WITH TWO NC EUPHORA BALLOONS TO POST DILATE. IT WAS ALSO REPORTED THAT THREE NC EUPHORA PTA BALLOONS WERE USED TO PRE DILATE THE VESSELS PRIOR TO TREATMENT. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS CASUALLY RELATED TO THE INDEX DEVICE BUT NOT RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 8739051 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX WAS IMPLANTED IN THE LAD AND TWO RESOLUTE ONYX STENTS WERE ALSO IMPLANTED IN THE CX. PLAQUE SHIFT OCCURRED IN THE LAD AND CX INTO THE LCMA WHICH WAS TREATED WITH THE IMPLANTATION OF TWO FURTHER RESOLUTE ONYX STENTS; ONE IN THE LAD AND ANOTHER IN THE CX WITH TWO NC EUPHORA BALLOONS TO POST DILATE. IT WAS ALSO REPORTED THAT THREE NC EUPHORA PTA BALLOONS WERE USED TO PRE DILATE THE VESSELS PRIOR TO TREATMENT. INVESTIGATOR ASSESSED THE EVENT AS CASUALLY RELATED TO THE INDEX DEVICE BUT NOT RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 8738975 ↗
• MalfunctionJul 30, 2018Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  AN NC EUPHORA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LAD - DIAGONAL BRANCH. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THE BALLOON BURST ON THE FIRST INFLATION AFTER 12 ATM OF PRESSURE HAD BEEN APPLIED WHILE BEING USED TO RE-DILATE A RE-STENOSED STENT. NO PATIENT COMPLICATIONS REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7731331 ↗
• MalfunctionAug 15, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN NC EUPHORA RX BALLOON CATHETER TO TREAT A LESION LOCATED IN THE PROXIMAL RAMUS. THE TARGET LESION WAS MODERATELY TORTUOUS, SEVERELY CALCIFIED WITH 99% STENOSIS. NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED, WITH NO ISSUES FOUND. NEGATIVE PREP WAS ALSO PERFORMED WITH NO ISSUES ENCOUNTERED. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THAT DETACHMENT OF THE BALLOON CATHETER OCCURRED INSIDE THE GUIDE CATHETER DURING ADVANCEMENT THROUGH GUIDE CATHETER. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DETACHED PORTION WAS REMOVED WITH THE 6F GUIDE CATHETER. THE BALLOON AND GUIDE CATHETER WERE BOTH REMOVED TOGETHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6793674 ↗
• InjuryAug 9, 2017Deflation Problem; Deflation Problem

  THE PHYSICIAN INTENDED TO USE AN NC EUPHORA RX BALLOON CATHETER TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD). THE TARGET LESION WAS REPORTED NOT TO BE TORTUOUS OR CALCIFIED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH/PACKAGING STYLETTE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED. THE LESION WAS PRE-DILATED. THE BALLOON WAS BEING USED TO POST DILATE A STENT. THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED DURING DELIVERY. ORIGINALLY, THE PRODUCT DID NOT INFLATE. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AFTER FIRST INFLATION, WHILE IN THE PATIENT. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. MD INTERVENED BY PULLING NEGATIVE WITH A SYRINGE AND BALLOON CAME DOWN ENOUGH TO BE REMOVED. PATIENT STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776247 ↗