NC Quantum Apex™ H7493912408450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729783206), received between Sep 8, 2025 and Nov 11, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Nonstandard Device; Failure to Advance; Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-OCT-2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A SMALLER SIZE OF NON-COMPLIANT BALLOON, AND AN 8MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519978 ↗
• MalfunctionSep 8, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH DOUBLE VESSEL DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE CHRONIC TOTALLY OCCLUDED TARGET LESIONS WERE LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND LEFT MAIN TO LEFT ANTERIOR DESCENDING ARTERY (LMLAD). AFTER SUCCESSFUL RCA INTERVENTION, PTCA TO LMLAD WAS PERFORMED UNDER INTRAVASCULAR ULTRASOUND (IVUS) GUIDANCE BY INSERTING 7F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER. THE LESION WAS CROSSED WITH A NON-BSC GUIDEWIRE, AND IVUS EVALUATION WAS DONE FOLLOWED BY STENTING IN THE LMLAD. AN 8MM X 4.50MM NC QUANTUM APEX? BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, ON THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998437 ↗