NC Euphora™ NCEUP3020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169395848), received between May 19, 2017 and Jun 20, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA BALLOON CATHETER DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS VERY SLOW TO DEFLATE AT THE LESION SITE. THE DEVICE WAS INSPECTED PRIOR TO USE AND 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. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296859 ↗
• InjuryJun 10, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER DRUG ELUTING CORONARY STENT AND ONE NC EUPHORA CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED FOR BOTH DEVICES. THE LESION BEING TREATED WAS NON-TORTUOUS, NON-CALCIFIED WITH 70% STENOSIS IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE BOTH INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOR BOTH DEVICES WITH NO ISSUES NOTED. THE ONYX FRONTIER DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE NC EUPHORA DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF BOTH DEVICES. THE ONYX FRONTIER DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE INFLATION DEVICE WAS CHANGED BUT DEFLATION WAS STILL UNSUCCESSFUL. AN EMPTY 30CC SYRINGE WAS USED, WHICH ALLOWED THE BALLOON TO PARTIALLY DEFLATE AND BE REMOVED FROM THE DRUG ELUTING STENT. THIS WAS FOLLOWED BY CONTINUED SLOW DEFLATION AND REMOVAL. THE NC EUPHORA BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THERE WERE MULTIPLE ATTEMPTS TO DEFLATE WITH THE INFLATION DEVICE WHICH WERE UNSUCCESSFUL. FOLLOWI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174073 ↗
• MalfunctionMay 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE NC EUPHORA CORONARY BALLOON CATHETER HAD BALLOON DEFLATION DIFFICULTIES AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS NOTED THAT POST BALLOON INFLATION, CONTRAST COULD NOT BE WITHDRAWN FROM THE LUMEN OF THE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076403 ↗
• InjuryNov 12, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS STATED THAT SURGERY WAS REQUIRED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20664479 ↗
• InjurySep 17, 2024Deflation Problem; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Deflation Problem; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA BALLOON TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED DURING INFLATION. IT WAS ALSO REPORTED THAT THE BALLOON WAS INFLATED TO A NOMINAL PRESSURE OF 12 ATMS BUT THEN AFTERWARDS THE BALLOON WOULD NOT DEFLATE. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 20235119 ↗
• InjuryAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE BALLOON BROKE OFF THE CATHETER IN RADIAL ARTERY REQUIRING RETRIEVAL. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20064021 ↗
• InjuryAug 29, 2022Burst 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 ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE PROXIMAL AND OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING A 2.5X15 NC EUPHORA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS  KINKED AND RESTRAIGHTENED DURING USE. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING THE SECOND BALLOON INFLATION AT 30 ATM. IT WAS ALSO REPORTED THAT THE BALLOON DETACHED DURING REMOVAL OF THE DEVICE. IT WAS STATED THAT THIS CASE INVOLVED A SEVERE CALCIFIED LESION THAT HAD BEEN SPUN WITH CSI RIGHT BEFORE THE BALLOON WAS USED. AFTER THE BALLOON BURST AT 30 ATM IT WAS ATTEMPTED TO BE REMOVED AND THE DISTAL PORTION OF THE BALLOON WAS CAUGHT ON CALCIUM. THE BALLOON WAS TORN FROM THE DELIVERY CATHETER AND WAS LEFT BEHIND IN THE VESSEL. AFTER SEVERAL ATTEMPTS TO REMOVE THE BALLOON MATERIAL BY SNARING, USING A BUDDY W

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

  MAUDE report 15309426 ↗
• InjuryApr 20, 2022Burst 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

  AN ATTEMPT WAS MADE TO USE A NON COMPLIANT (NC) EUPHORA BALLOON CATHETER IN A CALCIFIED LESION IN THE PROXIMAL DIAGONAL BRANCH. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A SEMI COMPLIANT (SC) EUPHORA DEVICE WAS USED TO PRE-DILATED A CALCIFIED LESION BUT WAS UNSUCCESSFUL. AN ATTEMPT WAS THEN MADE TO USE THE NC EUPHORA DEVICE TO INFLATE THE LESION, HOWEVER INFLATION ISSUES WERE ENCOUNTERED AS THE BALLOON BURST AT 18ATM. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE BUT THE BALLOON DETACHED FROM THE SHAFT. THE BALLOON SHEARED WHILE FORCIBLY TRYING TO BE REMOVED. A SNARE WAS USED BUT WAS UNSUCCESSFUL. A DECISION WAS MADE TO USE TWO RESOLUTE ONYX DEVICES, A 2.75X30MM AND A 2.75 X12MM RX TO ENSURE THE ENTRAPMENT OF THE SHEARED BALLOON. THE PATIENT WAS ON A BALLOON PUMP IN THE INTENSIVE CARE UNIT (ICU). NO FURTHER INJURY WAS REPORTED.

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

  MAUDE report 14157274 ↗
• MalfunctionNov 10, 2020Burst 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 ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL/MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST AT 20ATM, POST ORBITAL ATHERECTOMY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10815261 ↗
• MalfunctionFeb 11, 2020Fracture; Difficult to Remove; Detachment of Device or Device Component; Fracture; Difficult to Remove; Detachment of Device or Device Component

  A NC EUPHORA RX PTCA BALLOON CATHETER WAS USED DURING A RADIAL APPROACH TO TREAT A MILDLY CALCIFIED, SEVERELY TORTUOUS LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 6 FR LAUNCHER GUIDE CATHETER AND A 6 FR GUIDE LINER WERE USED OVER A NON-MEDTRONIC WIRE. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE WAS KINKED AND RE STRAIGHTENED DURING USE. THE LESION WAS PRE DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE DETACHED AT THE HUB INSIDE THE GUIDE LINER DURING REMOVAL DIFFICULTIES FOLLOWING BALLOON INFLATION. IT WAS ALSO REPORTED THAT EXCESSIVE FORCE WAS USED TO PULL THE BALLOON CATHETER OUT DUE TO THE SITE BEING EXTREMELY TORTUOUS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693621 ↗
• MalfunctionMay 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A NC EUPHORA TO TREAT A NON-CALCIFIED AND NON-TORTUOUS PROXIMAL LAD LESION. NO ISSUES WERE NOTED WITH THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE HOOP/ TRAY WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED SUCCESSFULLY. THE LESION WAS NOT PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OR EXCESSIVE FORCE REQUIRED. IT WAS REPORTED THAT THE PHYSICIAN FELT THE DEVICE SNAP WHEN ADVANCING THE NC EUPHORA THROUGH THE GUIDE CATHETER. THE DETACHMENT OCCURRED AT THE FEMORAL MARKER AND IT BROKE IN TWO PARTS. THE TIP OF THE DEVICE DID NOT EXIT THE GUIDE CATHETER. THE GUIDE CATHETER, WIRE AND BALLOON SHAFT WERE REMOVED FROM THE PATIENT AS ONE UNIT. EVERYTHING CAME OUT OF THE BODY. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6577671 ↗