NC Quantum Apex™ H7493912420270Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729783473), received between Jun 6, 2019 and Feb 5, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Nonstandard Device; Material Separation

  IT WAS REPORTED THAT A DETACHMENT OCCURRED. AN NC QUANTUM APEX MR 2.75 X 20MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. WHEN REMOVING THE BALLOON FROM THE PROTECTOR, THE PHYSICIAN NOTED THAT THE BALLOON WAS CUT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272187 ↗
• MalfunctionAug 20, 2025Nonstandard Device; Material Separation; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Material Separation; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING PREPARATION OF THE 20MM X 2.75MM NC QUANTUM APEX? BALLOON CATHETER, NO RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE BALLOON PROTECTOR/MANDREL BUT AFTERWARD, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849498 ↗
• MalfunctionNov 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 20MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING THE FOURTH INFLATION AT 20 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 3.00MMX20MM NC QUANTUM APEX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15878530 ↗
• MalfunctionJan 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. A 20MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS HANDED TO THE REPRESENTATIVE AND EXPLAINED THAT THE BALLOON CONTAINED AN EXPANSION CHART FROM AN ENTIRELY DIFFERENT BALLOON. THE BALLOON WAS NOT USED TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 11125323 ↗
• MalfunctionMay 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 20MM X 2.75MMM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043419 ↗
• MalfunctionFeb 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 20MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES TO OPTIMIZE THE STENT IMPLANT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677202 ↗
• MalfunctionJun 6, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. THE LESION CONTAINED >=90 DEGREES BEND. A 20MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION, BUT THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON WITH BUDDY WIRE SUPPORT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE AND DOING WELL. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SEPARATED HYPOTUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674131 ↗