NC Euphora™ NCEUP32520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169395787), received between Apr 26, 2019 and Apr 26, 2019 — 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.

• InjuryApr 26, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DURING A PROCEDURE AN NC EUPHORA RX PTCA BALLOON CATHETER WAS USED TO TREAT THE MID RCA. IT IS REPORTED THAT THE BALLOON RUPTURED WHEN INFLATED TO DILATE THE MID RCA. UPON EXTRACTING THE BALLOON IT WAS NOTED THAT PART OF THE BALLOON REMAINED IN THE RCA. THE BALLOON FRAGMENT WAS EXCLUDED BY REALIGNING THE VESSEL WITH AN OVERLAPPING STENT. THERE IS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8554104 ↗