NC Euphora™ NCEUP3008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169395879), received between Nov 7, 2018 and Jul 20, 2022 — classified as 1 injury, 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 18, 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.

• MalfunctionJul 20, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ONE 7F TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND ONE NC EUPHORA RX BALLOON CATHETER WERE ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE PROXIMAL - MID CIRCUMFLEX (CX) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE PACKAGING. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE NC EUPHORA DEVICE WAS NEGATIVELY PREPPED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS USED.  IT WAS REPORTED THAT DURING REMOVAL OF THE TELESCOPE GEC THE POLYMER ON-RAMP PEELED ALONG THE SHAFT, WHILE STILL ATTACHED TO THE CATHETER. IT WAS ALSO REPORTED THAT THE NC EUPHORA CATHETER SHAFT BROKE IN HALF DURING DELIVERY THROUGH THE VESSEL. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. THE DETACHED PORTION DOES NOT REMAIN IN THE PATIENT. NO PATIENT INJURY REPORTED.  IT WAS STATED THAT THE CASE WAS 4 HOURS LONG AND THE DEVICES WERE IN THE BODY FOR HOURS. IT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065014 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX WAS IMPLANTED IN THE LAD AND TWO RESOLUTE ONYX STENTS WERE ALSO IMPLANTED IN THE CX. PLAQUE SHIFT OCCURRED IN THE LAD AND CX INTO THE LCMA WHICH WAS TREATED WITH THE IMPLANTATION OF TWO FURTHER RESOLUTE ONYX STENTS; ONE IN THE LAD AND ANOTHER IN THE CX WITH TWO NC EUPHORA BALLOONS TO POST DILATE. IT WAS ALSO REPORTED THAT THREE NC EUPHORA PTA BALLOONS WERE USED TO PRE DILATE THE VESSELS PRIOR TO TREATMENT. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS CASUALLY RELATED TO THE INDEX DEVICE BUT NOT RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 8739027 ↗
• MalfunctionNov 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUE. 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 OF THE DEVICE. IT WAS REPORTED THAT DURING DELIVERY THROUGH THE VESSEL THAT THE BALLOON CATHETER BROKE AND DETACHED. THE DISTAL END OF THE CATHETER WAS REMOVED BY REMOVING THE GUIDE CATHETER. IT WAS REPORTED THAT THE BACK END OF THE DELIVERY SHAFT KINKED BUT NOT WHERE THE DELIVERY CATHETER BROKE. THE PATIENT IS REPORTED TO BE ALIVE NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8045591 ↗