NC Quantum Apex™ H7493912415270Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729783367), received between Nov 28, 2018 and Jul 15, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JUN2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED SEGMENT OF A CHRONIC TOTALLY OCCLUDED ARTERY. A 15 MM X 2.75 MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN CIRCUMFERENTIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510629 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 15MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, DURING PREPARATION AND ENGAGED INTO THE NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER, THE SHAFT BROKE APPROXIMATELY 57CM FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310567 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 92% STENOSED, 29MM X 2.75MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 2.75MM NC QUANTUM APEX WAS USED TO POST-DILATE A 32MM X 2.5MM STENT. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THE BALLOON SHAFT WAS BROKEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12019131 ↗
• MalfunctionNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-NOV-2019. A 15MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS USED IN A PROCEDURE WITH NO REPORTED ALLEGATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED LONGITUDINAL BALLOON TEAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9377472 ↗
• MalfunctionNov 18, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. WHEN THE BOX OF A 15MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS OPENED, IT WAS NOTED THAT THE DEVICE WAS BROKE INTO TWO FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9335964 ↗
• InjuryNov 7, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN INCORRECT COMPLIANCE CHART WAS IN THE PACKAGING. THE PHYSICIAN SELECTED A 15MM X 2.75MM NC QUANTUM APEX TO TREAT A 85% STENOSED TARGET LESION LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). UPON OPENING THE PACKAGE, A COMPLIANCE CHART FOR A 2.5 NC EMERGE WAS FOUND IN THE PACKAGING. THE PHYSICIAN ELECTED TO USE THE 15MM X 2.75MM NC QUANTUM APEX. THE PATIENT EXPERIENCED A DISSECTION DURING THE PROCEDURE REQUIRING TREATMENT WITH A 2.75X20 SYNERGY STENT. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 9289639 ↗
• MalfunctionApr 10, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, DURING THE START OF INFLATION, THE SHAFT RUPTURED AND BLOOD WENT BACK INTO THE INDEFLATOR. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW WIRE AND A 2.5 X 15 NC QUANTUM APREX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500999 ↗
• MalfunctionNov 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM EMERGE BALLOON AND A 15MM X 2.75MM NC QUANTUM APEX BALLOON WERE SELECTED FOR USE. DURING THE PROCEDURE, THE EMERGE BALLOON WAS INSERTED, FOLLOWED BY A NON BSC STENT AND THEN POST-DILATED WITH AN NC QUANTUM BALLOON. HOWEVER, IT WAS NOTED THAT BOTH EMERGE AND NC QUANTUM BALLOONS RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT HAS RECOVERED FULLY. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED MULTIPLE KINKS ALONG THE WHOLE DEVICE. MICROSCOPIC EXAMINATION REVEALED A PINHOLE IN THE BALLOON APPROXIMATELY 9MM FROM THE TIP. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN, INFLATION LUMEN, AND BALLOON. THE BALLOON IS LOOSELY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112400 ↗