NC Quantum Apex™ H7493912420220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729783459), received between Jan 4, 2021 and Oct 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionOct 28, 2022Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER THE NON-BOSTON SCIENTIFIC (BSC) WIRE CROSSED THE LESION, A 20MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. INFLATION WAS PERFORMED THREE TIMES AT 28 ATMOSPHERES. HOWEVER, DURING THE REMOVAL, THE BALLOON HAD DIFFICULTY PULLING BACK OFF FROM THE NON-BSC GUIDEWIRE DESPITE OF A LOT OF PERSISTENCE TO COMPLETE. EVENTUALLY, THE DEVICE WAS CAREFULLY AND FORCEFULLY RETRACED TO GET OFF THE GUIDE WIRE AND THE BALLOON REMOVED FULLY DEFLATED. IT WAS NOTED THAT THE BALLOON AND SHAFT APPEAR TO BE STRETCHED FROM PULLING. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692040 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 20MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE WHEN IT PASSED THROUGH THE 7FR GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11113364 ↗