NC Euphora™ NCEUP3508XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169396357), received between Nov 17, 2022 and Oct 16, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Deflation Problem; Device Damaged by Another Device; Deflation Problem; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT AND ONE NC EUPHORA CORONARY BALLOON TO TREAT A LESION. THE ONYX FRONTIER STENT WAS IMPLANTED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED WITH THE NC EUPHORA BALLOON, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE ONYX FRONTIER STENT WAS BEING POST-DILATED WITH THE NC EUPHORA BALLOON MID-STENT. ONE THE SECOND POST-DILATION INFLATION TO 6 ATM, THE BALLOON WASN'T FULLY DEFLATED. NEGATIVE WAS PULLED. A GUIDEWIRE WAS USED TO HELP DISLODGE THE BALLOON FROM THE STENT, HOWEVER, IN THE PROCESS THE STENT MOVED AND HAD TO BE RETRIEVED. THE STENT WAS FOUND IN THE ULNAR ARTERY AND WAS REMOVED BY A SNARE. THE NC EUPHORA BALLOON DEFLATED THE FIRST TIME BUT DID NOT DEFLATE AFTER THE SECOND INFLATION. THE CATHETER AND BALLOON DID NOT SEEM TO BE KINKED. THE PATIENT WAS FINE AND WAS DISCHARGED IN THE EVENING. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 20459305 ↗
• MalfunctionNov 17, 2022Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. THE BALLOON WOULD NOT INFLATE. THE BALLOON WAS REMOVED AND A SEPARATION OF THE WIRE AND SHAFT WERE NOTICED PROXIMAL TO THE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821800 ↗