NC Euphora™ NCEUP4008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169396234), received between Jul 23, 2020 and Nov 15, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO NC EUPHORA RX BALLOON CATHETERS TO TREAT A LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST OCCURRED WHEN USING BOTH DEVICES. IT WAS DETAILED THAT THE TWO NC EUPHORA BALLOON CATHETERS WERE USED TO POST DILATE A STENT. THE 4.00X8MM NC EUPHORA WAS INFLATED TWICE AT 16 ATM FOR 10SECONDS. THE BALLOON RUPTURED DURING THE SECOND DEFLATION. THE 4.0X20MM NC EUPHORA WAS THEN DILATED WITH TWO INFLATIONS AT 14ATM FOR 15SECONDS AND A THIRD INFLATION AT 14ATM FOR 10SECONDS. THE BALLOON RUPTURE OCCURRED DURING THE THIRD DEFLATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139854 ↗
• MalfunctionNov 26, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT AND AN NC EUPHORA BALLOON CATHETER TO TREAT A LIMITED TORTUOUS LESION WITH 85% STENOSIS IN THE MID LAD. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. THE DEVICES WERE NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED AT THE CATHETER DURING ADVANCEMENT THROUGH THE NON-MEDTRONIC (MDT) GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE NC EUPHORA CATHETER BECAME DETACHED IN TWO PIECES IN THE GUIDE CATHETER. IT WAS SUGGESTED THAT THE BALLOON MAY HAVE BECOME TWISTED DUE TO TWO NON-MDT GUIDE WIRES INSIDE THE GUIDE CATHETER. IT WAS ATTEMPTED TO PASS THE RESOLUTE ONYX THOUGH AND WAS ALSO SUGGESTED THAT THE STENT BECAME PARTIALLY DISLODGED OR GOT CAUGHT WITH THE BALLOON. THE DEVICES WERE EASILY REMOVED. THE DEVICES NEVER REACHED THE PATIENT VESSEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877341 ↗
• MalfunctionJul 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL 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. IT WAS REPORTED THAT THE DEVICE DETACHED AT THE CATHETER DURING ADVANCEMENT THROUGH THE GUIDE CATHETER AND NEVER EXITED THE GUIDE. THE DEVICE WAS NOT KINKED OR RESTRAIGHTENED DURING USE. THE DETACHED PORTION WAS REMOVED BY PULLING THE DEVICE OUT OF THE GUIDE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312637 ↗