NC Quantum Apex™ H7493912408350Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729783176), received between Nov 26, 2018 and May 7, 2026 — classified as 1 death, 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH 2.50 X 15MM SEMI COMPLIANT BALLOON CATHETER. A 3.00 X 32MM SYNERGY SHIELD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. POST-DEPLOYMENT, AN 8MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, WHILE LOADING ON WIRE, THE SHAFT WAS BROKEN. ANOTHER 3.50MM X 8MM NC BALLOON CATHETER WAS USED TO POST-DILATE THE LESION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116438 ↗
• MalfunctionNov 7, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AN 8MM X 3.50MM NC QUANTUM APEX MR WAS ADVANCED FOR PRE-DILATION BUT FAILED TO CROSS THE ANGULATED LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SMALLER SIZED BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498291 ↗
• MalfunctionMar 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE PATIENT, DIAGNOSED WITH CORONARY ARTERY DISEASE (CAD), WAS ADMITTED FOR CARDIAC CATHETERIZATION TO UNDERGO PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). A 90% STENOSED TARGET LESION WAS IDENTIFIED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. THE PROCEDURE BEGAN WITH CANNULATION OF THE ARTERY USING A 3.5 MACH FR CATHETER. THE SAMURAI CORONARY GUIDE WAS THEN ADVANCED, AND AN 8MM X 3.5MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR THE INTERVENTION. HOWEVER, WHILE ATTEMPTING TO ADVANCE THE BALLOON THROUGH THE GUIDE CATHETER, THE PROXIMAL SEGMENT OF THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602018 ↗
• MalfunctionJan 31, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. A 2.00X12 MAVERICK BALLOON WAS ADVANCED FOR DILATATION BUT FAILED TO CROSS THE LESION AND WAS REPLACED WITH A NON-BOSTON SCIENTIFIC (BSC) BALLOON. FOLLOWING PRE-DILATATION, A 3.00X16 AND 2.50X24 SYNERGY DRUG-ELUTING STENTS WERE ADVANCED INTO THE LAD AND LCX RESPECTIVELY BUT FAILED TO CROSS. BOTH STENTS WERE REMOVED AND REPLACED WITH TWO NON-BSC STENTS. A 2.75X8 NC QUANTUM APEX BALLOON WAS USED TO OPTIMIZE THE PROXIMAL PORTION OF LCX STENT, WHILE A 3.50X8 NC QUANTUM APEX BALLOON WAS ADVANCED BUT FAILED TO CROSS AND GOT STUCK IN THE PROXIMAL PORTION OF THE LAD STENT AND WAS REMOVED WITH SOME DIFFICULTY. ANOTHER 3.50X8 NC QUANTUM APEX BALLOON WAS USED TO COMPLETE THE PROXIMAL OPTIMIZATION TECHNIQUE SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274248 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85-95% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 8MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT WAS REPORTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463230 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 92% STENOSED, 8MM X 3.50MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN ARTERY. A 8MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE BALLOON SHAFT WAS BROKEN. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658054 ↗
• MalfunctionMar 23, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS TREATED FOR CORONARY ARTERY DISEASE FOR LESION LOCATED IN A DE NOVO VESSEL. AN 8MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED BEFORE USE. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556174 ↗
• MalfunctionJun 9, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE BALLOON FROZE ON THE WIRE. A PROCEDURE WAS BEING COMPLETED WITH THE USE OF A 8MM X 3.5MM NC QUANTUM APEX BALLOON CATHETER. AS THE BALLOON WAS BEING WITHDRAWN AFTER ITS USE, IT BECAME STUCK ON THE 190CM SAMURAI GUIDEWIRE. THE BALLOON WAS NOT ABLE TO BE REMOVED BY ITSELF, SO IT WAS REMOVED WITH THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED TO HAVE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135685 ↗
• InjuryAug 19, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED RIGHT CORONARY POSTERIOR DESCENDING ARTERY. A 8 MM X 3.50 MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON CATHETER WAS FRACTURED. A 4 MM SNARE WAS USED TO RETRIEVED THE DEVICE AND IT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS IMPLANTED WITH A 2.25 X 16 SYNERGY STENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8905575 ↗
• 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 8101571 ↗