NC Euphora™ NCEUP22520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169396029), received between Feb 26, 2020 and Dec 8, 2020 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT 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 NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE DETACHED AT THE CATHETER DURING DELIVERY THROUGH THE VESSEL. THE DETACHED PORTION OF THE STENT CATHETER WAS REMOVED SAFELY BY TRAPPING IT WITH A CORONARY BALLOON INSIDE A TURNPIKE GUIDE EXTENSION CATHETER AND REMOVING FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY. A NC EUPHORA RX BALLOON CATHETER RETURNED ALONG SIDE THE RESOLUTE ONYX WITH A DETACHMENT ON THE HYPERTUBE. DURING ANALYSIS, IT WAS NOTED THAT A KINK WAS IDENTIFIED ON BOTH SIDES OF THE HYPERTUBE. THE BALLOON FOLDS WERE EXPANDED AND BLOOD WAS VISIBLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968374 ↗
• InjuryFeb 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA PTCA BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT DURING ROUTINE PERCUTANEOUS CORONARY INTERVENTION THE BALLOON SHAFT BROKE OFF BEFORE ENTERING THE PATIENTS BODY. IT WAS STATED THAT INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT SERIOUS INJURY OCCURRED.

  Patient problems: Injury

  MAUDE report 9756995 ↗