NC Euphora™ NCEUP27508XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169396111), received between Dec 19, 2017 and May 1, 2024 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMay 1, 2024Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX BALLOON CATHETER TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE EXPERIENCED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219342 ↗
• InjuryDec 19, 2017Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED THAT AN NC EUPHORA DEVICE HAD A MICRO HOLE WHEN INFLATED, WHICH MAY HAVE CAUSED A SEPTAL DISSECTION. A SMALL PINHOLE LEAK ON THE BALLOON CAUSED CONTRAST TO LEAK OUT. THE PATIENT IS REPORTED AS STABLE AND HAS HAD SOME MILD ANGINA POST CASE AND IS STAYING OVERNIGHT IN HOSPITAL. THE REST OF THE CASE WENT WELL.

  Patient problems: Angina; Vascular Dissection

  MAUDE report 7127999 ↗