NC Quantum Apex™ H7493912430270Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729783589), received between Sep 8, 2020 and Oct 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 30MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED TWICE AT 28 ATMOSPHERES. HOWEVER, THE BALLOON WAS VERY DIFFICULT TO REMOVE FROM A NON-BSC GUIDEWIRE ALTHOUGH IT WAS IN FULLY DEFLATED STATE. EVENTUALLY, THE DEVICE WAS ABLE TO BE PULLED OFF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691726 ↗
• MalfunctionNov 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 30MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED.

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

  MAUDE report 10896908 ↗
• MalfunctionSep 8, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-AUG-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE CALCIFIED TARGET LESION WAS LOCATED IN A A 30MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE PLACED STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10501463 ↗