NC Quantum Apex™ H7493912420400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729783527), received between Aug 24, 2022 and Jun 20, 2024 — classified as 3 malfunctions.

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

• MalfunctionJun 20, 2024Material Integrity Problem; Failure to Deflate; Material Integrity Problem; Failure to Deflate

  IT WAS REPORTED THAT A DEFLATION ISSUE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUSLY LOW AND MODERATELY TO HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.00MM X 20MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS NOT ABLE TO GO DOWN. THE DEVICE WAS PULLED OUT AND IT WAS OBSERVED THAT THE BALLOON WAS KINKED. A 4.00MM X 20MM NC EMERGE BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574669 ↗
• MalfunctionOct 28, 2022Inflation Problem; Positioning Problem; Inflation Problem; Positioning Problem

  AGENT IDE STUDY. IT WAS REPORTED THAT AN INFLATION PROBLEM OCCURRED. IN APRIL 2022, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS RANDOMIZED INTO THE AGENT IDE STUDY AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. HEPARIN OR ANTITHROMBOTIC MEDICATION AND GP IIB/IIIA INHIBITOR WERE ADMINISTERED AT THE TIME OF INDEX PROCEDURE. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AND ANTIPLATELET MEDICATION OTHER THAN ASPIRIN (>= 72 HOURS) AT THE TIME OF INDEX PROCEDURE. A LOADING DOSE OF 324 MG OF ASPIRIN AND 600 MG OF CLOPIDOGREL WERE GIVEN PRIOR TO THE PROCEDURE. THE 70% IN-STENT RESTENOSED TARGET LESION WAS LOCATED AT THE DISTAL RIGHT CORONARY ARTERY (RCA) AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION WAS PREDILATED WITH 4.0 MM X 20 MM BALLOON WITH 20% RESIDUAL STENOSIS WITH TIMI FLOW 3. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH 4.0 MM X 20 MM NC QUANTUM APEX. SLIPPING OF THE BALLOON WAS NOTED, BUT THE TARGET LESION WAS TREATED SUCCESSFULLY WITH 15% RESIDUAL STENOSIS AND TIMI FLOW 3. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691070 ↗
• MalfunctionAug 24, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN ADDITIONAL MARKER BAND WAS ON THE DEVICE. AN EMERGE BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED INTO THE PATIENT. IT WAS OBSERVED THAT THE EMERGE BALLOON CATHETER HAD 3 MARKER BANDS INSTEAD OF 2. THE EMERGE BALLOON CATHETER WAS NOT DILATED. THE EMERGE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285771 ↗