NC Euphora™ NCEUP2506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169395954), received between Oct 27, 2017 and Dec 19, 2017 — classified as 2 malfunctions.

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.

• MalfunctionDec 19, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS USING AN NC EUPHORA DEVICE TO TREAT A NON-TORTUOUS AND SEVERELY CALCIFIED LESION IN THE PROXIMAL CX ARTERY. THE PHYSICIAN WAS USING THE NC EUPHORA BALLOON CATHETER TO FURTHER EXPAND A PREVIOUSLY DEPLOYED NON MEDTRONIC STENT, THAT HAD BEEN IMPLANTED 1 WEEK PREVIOUSLY. THE PREVIOUSLY IMPLANTED STENT WAS DETERMINED TO BE UNDER EXPANDED BY 50%. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE IDENTIFIED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED. NO RESISTANCE WAS NOTED DURING DELIVERY OF THE DEVICE TO THE LESION, OR DURING WITHDRAWAL OF THE DEVICE FROM THE LESION. THE DEVICE PASSED THROUGH THE PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE PREVIOUSLY DEPLOYED STENT WAS NOT ABLE TO FULL EXPAND WHEN IMPLANTED. THE PATIENT WAS BROUGHT BACK FOR LASER AND FURTHER STENT EXPANSION WAS REQUIRED DUE TO HEAVY CALCIFICATION OF THE VESSEL, AND STENOSIS INSIDE OF THE PREVIOUSLY IMPLANTED STENT. THE NC EUPHORA WAS INFLATED TO 34 ATM, AND IT WAS THEN NOTED THAT THE SHAFT OF THE DEVICE BECAME DEFORM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127921 ↗
• MalfunctionOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A NC EUPHORA PTCA BALLOON CATHETER TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON WAS EXPIRED (APPROX 31 DAYS PAST ITS EXPIRATION DATE). IN A STEMI CASE THE PHYSICIAN REQUESTED A EUPHORA BALLOON 2.5 X 6 RX AND THE STAFF RETRIEVED THE UNIT FROM THE INVENTORY AREA. BEFORE THE PACKAGE WAS OPENED, IT WAS THEN NOTED BY THE STAFF THE UNIT HAD AN EXPIRATION DATE OF 9-1-2017 AND THE PHYSICIAN WAS INFORMED. THE PHYSICIAN REQUESTED TO OPEN THE PACKAGE AND USE THE BALLOON WITH FULL KNOWLEDGE OF THE EXPIRATION DATE. NO INTERVENTION WAS USED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY. PATIENT IS STABLE AND WAS DISCHARGED FROM HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6982786 ↗