NC Quantum Apex™ H7493912408270Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729783145), received between Nov 26, 2018 and Dec 9, 2025 — classified as 2 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionDec 9, 2025Nonstandard Device; Failure to Advance; Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 24NOV2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN 8MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. BUT THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758669 ↗
• MalfunctionApr 28, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 8MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. ONCE REACHED THE REQUIRED LOCATION, THE BALLOON WAS EXPANDED WITH MINIMAL PRESSURE. HOWEVER, DURING POST DEFLATION, THE SURGEON WAS UNABLE TO DRAW BACK THE BALLOON. THE BALLOON WAS INFLATED AND DEFLATED TO REMOVE IT OUT OF VESSEL. ALTERNATE DILATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246211 ↗
• MalfunctionApr 18, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 75% STENOSED, MILDLY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. WHILE ADVANCING THE 8MM X 2.75MM NC QUANTUM APEX BALLOON THROUGH THE GUIDING CATHETER, THE BALLOON CATHETER SHAFT BROKE AND THE TWO PARTS WERE REMOVED FROM THE VESSEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528618 ↗
• DeathNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DIED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 3.5X20MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION CONTAINED A BEND BETWEEN 45 AND 90 DEGREES. FOLLOWING PRE-DILATION, TWO NON-BSC STENT WERE IMPLANTED TO TREAT THE TARGET LESION. POST-DILATION WAS PERFORMED WITH TWO 2.75X8MM NC QUANTUM APEX BALLOON CATHETERS AND A 3.50X8MMNC QUANTUM APEX BALLOON CATHETER. THE PATENT WAS SHIFTED TO CORONARY CARE UNIT AND DIED. NO AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 8101636 ↗
• DeathNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DIED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 3.5X20MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION CONTAINED A BEND BETWEEN 45 AND 90 DEGREES. FOLLOWING PRE-DILATION, TWO NON-BSC STENT WERE IMPLANTED TO TREAT THE TARGET LESION. POST-DILATION WAS PERFORMED WITH TWO 2.75X8MM NC QUANTUM APEX BALLOON CATHETERS AND A 3.50X8MMNC QUANTUM APEX BALLOON CATHETER. THE PATENT WAS SHIFTED TO CORONARY CARE UNIT AND DIED. NO AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 8101628 ↗