NC Quantum Apex™ H7493912430250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729783572), received between Nov 13, 2018 and Jul 1, 2024 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Material Rupture; Wrong Label; Material Rupture; Wrong Label

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. DURING A PROCEDURE, FOLLOWING ROTABLATION, A DEVICE WITH PACKAGE LABEL OF NC QUANTUM APEX 2.5 X 30MM WAS SELECTED FOR USE. HOWEVER, THE INNER PACKAGE CONTAINED A 3.5 X 30MM NC QUANTUM APEX IN SIZE. THE OVERSIZED DEVICE RESULTED IN A CORONARY PERFORATION. THE PERFORATION WAS COVERED WITH A NON-BSC STENT. THE PATIENT WAS STABILIZED AND EXPECTED TO FULLY RECOVER.

  Patient problems: Perforation of Vessels

  MAUDE report 19644072 ↗
• MalfunctionApr 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED CORONARY ARTERY. A 30MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048311 ↗
• InjuryOct 29, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 30MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING REMOVAL, THE DISTAL PORTION REMAINED IN PATIENT DUE TO A BEND. THE DEVICE WAS COMPLETELY REMOVED BY TRAPPING THE WIRE AND INFLATING ANOTHER BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10757988 ↗
• MalfunctionAug 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 30MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 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 8899771 ↗
• MalfunctionNov 13, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 30MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS ATTEMPTED TO BE REMOVED FOLLOWING DEFLATION, THE BALLOON DID NOT SLIDE EASILY AND BECAME STUCK TO THE GUIDE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN MANAGED TO WITHDRAW THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8067144 ↗