NC Euphora™ NCEUP4006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169396241), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 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 LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOON BURST AND THE TIP OF THE BALLOON REMAINED IN THE ARTERY AFTER BURSTING. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14571912 ↗