NC Euphora™ NCEUP3527XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169396319), received between Jan 26, 2024 and Nov 26, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Deflation Problem; Detachment of Device or Device Component; Positioning Problem; Deflation Problem; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING  WITH ONE NC EUPHORA RX CORONARY BALLOON CATHETER, DEFLATION DIFFICULTIES OCCURRED. THE BALLOON FAILED TO DEFLATE IN THE MID RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED SEVERE CALCIFICATION, MILD TORTUOSITY AND 99% LESION STENOSIS. THE DEVICE WAS INSPECTED  PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. AS A RESULT OF THE DEFLATION DIFFICULTIES, THE PATIENT REQUIRED A CORONARY ARTERY BYPASS SURGERY OF THE RCA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654249 ↗
• MalfunctionAug 27, 2024Deflation Problem; Inflation Problem; Material Deformation; Deflation Problem; Inflation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO NC EUPHORA BALLOON CATHETERS TO TREAT A LESION WITH CHRONIC TOTAL OCCLUSION (CTO 100% STENOSIS). THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES 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. IT WAS REPORTED THAT THE INFLATION ON BOTH BALLOONS WAS SLOW AND THE BALLOONS WOULD NOT DEFLATE. ALL ACCESS DEVICES HAD TO BE REMOVED.  THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075241 ↗
• MalfunctionAug 27, 2024Deflation Problem; Inflation Problem; Material Deformation; Deflation Problem; Inflation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO NC EUPHORA BALLOON CATHETERS TO TREAT A LESION WITH CHRONIC TOTAL OCCLUSION (CTO 100% STENOSIS). THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES 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. IT WAS REPORTED THAT THE INFLATION ON BOTH BALLOONS WAS SLOW AND THE BALLOONS WOULD NOT DEFLATE. ALL ACCESS DEVICES HAD TO BE REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075193 ↗
• InjuryJan 26, 2024Burst Container or Vessel; Deflation Problem; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Deflation Problem; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR D ESCENDING (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID 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 BALLOON DEFLATION DIFFICULTIES OCCURRED. THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON HAD TO BE RUPTURED BY INFLATION TO ALLOW BALLOON FLOW. THE BALLOON THEN BECAME STUCK AND FRACTURED DURING REMOVAL. THE DISTAL TIP AND BALLOON WERE LEFT IN LAD. ANOTHER STENT WAS DEPLOYED TO POST DILATE AND STABILIZE THE BALLOON. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Obstruction/Occlusion

  MAUDE report 18585772 ↗