NC Quantum Apex™ H7493912430220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729783565), received between Dec 14, 2018 and Jun 2, 2022 — classified as 4 malfunctions.

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

• MalfunctionJun 2, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. A 30MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS INFLATED ABOVE RATED BURST PRESSURE AT 26 ATMOSPHERES, THE BALLOON LUMEN APPEARED TO COLLAPSE AND WILL NOT PULL BACK OFF THE GUIDEWIRE EASILY. THE PHYSICIAN DEFLATED BALLOON ENTIRELY, AND HAD EXTREME DIFFICULTY IN TRYING TO REMOVE IT FROM THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577858 ↗
• MalfunctionFeb 3, 2021Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-JAN-2021. IT WAS REPORTED THAT DIFFICULTY ADVANCING THROUGH THE GUIDE CATHETER OCCURRED. A 30MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON DID NOT ADVANCE OVER THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT HOLE IN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276666 ↗
• MalfunctionNov 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 30MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

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

  MAUDE report 10896758 ↗
• MalfunctionDec 14, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 30MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. FOLLOWING BALLOON DEFLATION, THE DEVICE BECAME TRAPPED ON THE GUIDEWIRE. THE GUIDEWIRE WAS MOVED FROM THE CORONARY WHEN THE BALLOON WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166024 ↗