NC Euphora™ NCEUP4515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169396166), received between Apr 4, 2022 and Feb 3, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA BALLOON CATHETER TO TREAT A NON-TORTUOUS, MODERATELY CALCIFICATION LESION IN THE OSTIUM LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A CATHETER DETACHED/FRACTURE OCCURRED DURING DELIVERY THROUGH THE VESSEL. THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT, AND WAS PULLED OUT MANUALLY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16289777 ↗
• MalfunctionApr 4, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A NC EUPHORA RX BALLOON CATHETER TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE LESION WAS PRE-DILATED AND A STENT PLACED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING THE SECOND INFLATION OF THE DEVICE AT 10 ATM. IT WAS STATED THAT THE FIRST INFLATION WAS PERFORMED WITH NO ISSUE, HOWEVER ON THE SECOND INFLATION PRESSURE WAS LOST AND IT WAS DISCOVERED THAT THE BALLOON HAD RUPTURED.  AN ATTEMPT WAS MADE TO PULL THE DEVICE BACK, BUT THE DISTAL PART OF THE BALLOON WAS FOUND TO BE DETACHED FROM THE SHAFT. THE PHYSICIAN WAS ABLE TO TRAP THE DETACHED PORTION OF THE BALLOON INSIDE GUIDE AND REMOVED IT. UPON REMOVAL THE TIP OF THE BALLOON WAS STILL INSIDE THE GUIDE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994555 ↗