NC Quantum Apex™ H7493912412350Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729783282), received between Jan 15, 2019 and Sep 21, 2026 — classified as 1 death, 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Break

  It was reported shaft break occurred requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery. A 12mm x 3.50mm NC Quantum Apex? balloon catheter was selected for use. However, during the attempts to cross the lesion, it was noticed that the shaft was broken into two pieces. The device was completely removed using snare. The procedure was completed with another 12mm x 3.50mm NC Quantum Apex MR balloon catheter. No further complications were reported, and the patient status was stable post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844363 ↗
• MalfunctionSep 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A COMET II PRESSURE GUIDEWIRE WAS SELECTED AND FAILED WHEN PLUGGED IN TO THE LINK AND WAS UNABLE TO OBTAIN A WIRE PRESSURE. THE WIRE WAS THEN REPLACED WITH ANOTHER COMET II AND FRACTIONAL FLOW RESERVE (FFR) WAS COMPLETED. DURING THE SAME PROCEDURE, A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED, AND NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816498 ↗
• MalfunctionJul 17, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION ON THE STENOSED TARGET LESION, LOCATED IN THE TORTUOUS AND CALCIFIED HEMOSTATIC VALVE. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PREPARATION OF THE PROCEDURE OUTSIDE THE PATIENT, THE NC QUANTUM APEX BALLOON CATHETER SHAFT BROKE IN THE MIDDLE. THE NC QUANTUM APEX BALLOON CATHETER WAS RETRIEVED AND UNWOUND FROM THE GUIDEWIRE WITHOUT HARMING THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NC QUANTUM APEX BALLOON CATHETER. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17338159 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING REMOVAL OF THE DEVICE, THE DISTAL END OF THE SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317149 ↗
• MalfunctionJun 22, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INSERTION, THE SHAFT WAS BROKEN. THE DEVICE WAS SIMPLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185767 ↗
• MalfunctionJun 6, 2022Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, PRIOR TO PROCEDURE, THE PACKAGE WAS NOTED TO BE CRUSHED AND HAS WATER DAMAGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602865 ↗
• InjuryMar 31, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN ARTERY. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AND COMPLETELY CAME OFF THE SHAFT. A SNARE WAS USED TO TRY AND RETRIEVE THE BALLOON FRAGMENT BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE BALLOON FRAGMENT WAS STENTED IN THE LEFT MAIN ARTERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13971670 ↗
• InjuryMar 2, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH # (B)(4) THAT A BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. DURING CARDIAC CATHERIZATION REVASCULARIZATION PROCEDURE, A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS BEING ADVANCED FOR POST DILATION. HOWEVER, THERE WAS RUPTURE OF BALLOON IN THE STENTED POST DILATION WHICH CAUSED THE BALLOON TO ENTRAP WITHIN THE STENTED SEGMENT. THE DISTAL TIP OF THE BALLOON DISENGAGED FROM THE SHAFT. INITIAL CAPTURE OF THE DISTAL TIP OF THE BALLOON WAS ACCOMPLISHED WITH A SNARE AND PULLED INTO THE GUIDE BUT THEN IT BECAME EMBOLIZED INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE WERE MULTIPLE WIRES PLACED INTO THE LAD TO TRY TO PULL THE BALLOON TIP BACK INTO THE GUIDE, ULTIMATELY A 4MM SNARE WAS ABLE TO TRAP THE DISTAL TIP AND THE ENTIRE SYSTEM WAS REMOVED. THE BALLOON TIP WAS VISUALIZED OUTSIDE THE BODY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Embolism/Embolus

  MAUDE report 13653885 ↗
• MalfunctionJan 5, 2022Break; Failure to Advance; Break; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30DEC2021. IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, DE NOVO TARGET LESION WITH A SIGNIFICANT BEND OF >= 90 DEGREES WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION BUT DID NOT CROSS THE LESION AFTER MULTIPLE ATTEMPTS AND THE SHAFT BROKEN 6CM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE BREAK WAS 21CM FROM THE HUB, IN A LOCATION WHICH COULD ENTER THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172938 ↗
• DeathJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE DE NOVO TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER AND A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WERE USED DURING THE PROCEDURE, AND A 3.00X38MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE OUTPUT WAS LOW. THE PATIENT DEVELOPED A PROBLEM AND SUBSEQUENTLY DIED THE NEXT DAY.

  Patient problems: Death

  MAUDE report 11233516 ↗
• MalfunctionJul 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT 18 ATMOSPHERES FOR 10 SECONDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10265158 ↗
• MalfunctionJun 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184821 ↗
• MalfunctionJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19DEC2019. A 12MMX3.50MM NC QUANTUM APEX WAS RETURNED WITH NO REPORTED ISSUES. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON SEPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575964 ↗
• MalfunctionNov 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATION. THE BALLOON WAS INFLATED AT THE DISTAL PART OF THE STENT. THE BALLOON WAS PULLED BACK TO FURTHER DILATE THE STENT. HOWEVER, DURING INFLATION, THE BALLOON BROKE OFF AND HALF OF IT WAS STILL ATTACHED TO THE BALLOON CATHETER. THE BALLOON CATHETER WAS REMOVED AS WELL AS THE NON-BSC WIRE WHICH STILL HAD THE REST OF THE BALLOON ON IT. THE LESION WAS RE-WIRED AND ANOTHER OF THE SAME DEVICE WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9343749 ↗
• MalfunctionOct 3, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. WHILE THE DEVICE WAS OUTSIDE THE PATIENT DURING A PROCEDURE INVOLVING A 12MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE WAS SPLIT IN ITS DISTAL PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9153569 ↗
• MalfunctionJan 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 12MM X 3.50MM NC QUANTUM APEX BALLOON WAS SELECTED FOR PRE-DILATION. HOWEVER, UPON SECOND INFLATION AT 14 BAROMETRIC PRESSURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247893 ↗