NC Quantum Apex™ H7493912412300Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729783268), received between Mar 20, 2017 and Aug 21, 2025 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE. A 12 X 3.00 MM NC QUANTUM APEX WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). NO DAMAGE WAS OBSERVED DURING UNPACKING OR PREPARATION, AND THE DEVICE ADVANCED SMOOTHLY OVER THE WIRE AND GUIDEWIRE. DURING THE PROCEDURE, THE BALLOON TIP DETACHED FROM THE CATHETER. IT WAS SUCCESSFULLY RETRIEVED BY USING A SECOND BALLOON TO EXTRACT IT FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864692 ↗
• MalfunctionJan 5, 2024Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2023. IT WAS REPORTED THAT SHAFT KINK OCCURRED. UPON UNPACKING OF A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER, THE SHAFT WAS NOTICED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454212 ↗
• InjuryAug 7, 2023Break; Break

  IT WAS REPORTED A SHAFT BREAK OCCURRED, FOLLOWED BY A DISSECTION AND HEMATOMA, REQUIRING ADDITIONAL INTERVENTION. A NC QUANTUM APEX BALLOON AND A SYNERGY II DES STENT BALLOON WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE BALLOON FRACTURED AND HAD TO BE RETRIEVED. THE INTACT, FRACTURED BALLOON WAS TRAPPED INSIDE THE GUIDE CATHETER USING THE GUIDEWIRE AND THE ENTIRE SYSTEM WAS REMOVED. IVUS SHOWED A DISSECTION AND HEMATOMA. THE CAUSE FOR THE REPORTED DISSECTION AND HEMATOMA REMAINS UNKNOWN. ADDITIONAL STENTING WAS PERFORMED TO RESOLVE THE INJURIES. THE PATIENT WAS FULLY RECOVERED. ADDITIONAL INFORMATION: IT WAS FURTHER REPORTED THAT THE SEVERELY CALCIFIED, MODERATELY TORTUOUS, 80% STENOSED BIFURCATION LESION WAS LOCATED IN THE OSTIAL DIAGONAL AND EVOLVED TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ADDITIONALLY, THERE WAS A PREVIOUSLY IMPLANTED UNDER-EXPANDED STENT. THE PATIENT WAS PRESENTING WITH CHEST PAIN, BELIEVED TO BE CAUSED BY THE UNDER-EXPANDED STENTS. INTRAVASCULAR ULTRASOUND(IVUS) CONFIRMED A GAP AT THE OSTIAL DIAGONAL, AND THIS WAS THE TARGET REGION TO STENT. HOWEVER, THE STENT COULD NOT BE DELIVERED. THE LAD STENT WAS BALLOONED FURTHE

  Patient problems: Hematoma; Vascular Dissection

  MAUDE report 17477075 ↗
• MalfunctionJun 26, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INSERTION, A SLIGHT RESISTANCE WAS FELT, AND WHEN MINIMAL FORCE WAS APPLIED, THE PROXIMAL SHAFT WAS COMPLETELY FRACTURED AT APPROXIMATELY 15CM FROM THE HUB. THE DEVICE WAS RETRIEVED FROM THE PATIENT WITHOUT ANY COMPLICATIONS AND PHYSICIAN DECIDED TO JUST REFER FOR THE CONSULTATION INSTEAD OF ATTEMPTING ANOTHER BALLOON INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198010 ↗
• MalfunctionMay 2, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. FOLLOWING THE DEPLOYMENT OF STENT, PHYSICIAN DECIDED TO DO KISSING BALLOONS. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED WITH ANOTHER 4.0MM BALLOON. THE BALLOONS WERE ADVANCED AND GET AN ADEQUATE EXPANSION AND A SUCCESSFUL OUTCOME. HOWEVER, WHILE PULLING OUT THE 3.0 X 12 NC QUANTUM APEX FROM THE PATIENT'S BODY, THE MID SHAFT OF THE BALLOON BROKE 65 CM FROM THE HUB. THE BALLOONS WERE REMOVED FROM THE BODY FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858113 ↗
• MalfunctionAug 3, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR TREATMENT TO A 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED IN LEFT ANTERIOR DESCENDING ARTERY. THE NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. THE DEVICE FAILED TO INFLATE. BLOOD WAS NOTICED WITHIN THE BALLOON CATHETER. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158701 ↗
• MalfunctionMar 4, 2022Break; 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 TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 12MM X 3.00MM NC QUANTUM APEX MR WAS ADVANCED TO THE LAD. FOLLOWING INFLATION AND DEFLATION, A BROKEN PORTION OF THE BALLOON WAS NOTICED. TO REMOVE THE DETACHED PORTION OF THE DEVICE, ALL SYSTEMS INCLUDING GUIDEWIRE, GUIDE CATHETER, AND BALLOON DEVICE WERE DRAWN BACK TOGETHER, AND REMOVED FROM THE PATIENT. IT WAS NOTED THAT THE FRACTURE OCCURRED APPROXIMATELY AT THE MIDDLE PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13672471 ↗
• MalfunctionJan 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE FIBROTIC AND DIFFUSELY DISEASED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN CANNULATED A GUIDE CATHETER AT THE LEFT MAIN OSTIUM AND CROSSED THE LESION WITH A GUIDEWIRE. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252959 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT SHAFT BREAK OCCURED. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE BEING PUSHED INTO THE CORONARY ARTERY, THE BALLOON SHAFT BROKE IN TWO. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 3.0 X 12 NC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594252 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON TRYING TO ADVANCE THE BALLOON AND ENGAGE THE LESION, THE PROXIMAL SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW NC QUANTUM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509793 ↗
• MalfunctionMay 26, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT MARKER BAND MISALIGNMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 80% STENOSED, 32MM X 30MM, TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING INFLATION, IT WAS NOTICED THAT THE BALLOON MARKER BANDS WERE NOT IN THE RIGHT POSITION. THE PROXIMAL MARKER WAS VISIBLE IN THE MID OF THE BALLOON WHILE THE DISTAL MARKER PLACED OUT OF THE INFLATION AREA. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891033 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE DE NOVO TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, THE BALLOON SHAFT WAS BROKEN. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIEN'S BODY AS A WHOLE TOGETHER. THE PHYSICIAN USED A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10968207 ↗
• MalfunctionAug 28, 2020Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 75% STENOSED, MODERATELY CALCIFIED AND MODERATELY TO SEVERE TORTUOUS LESION. A 12X3.00MM NC QUANTUM APEX BALLOON WAS DIFFICULT TO TRACK OVER THE GUIDEWIRE AND THE SHAFT OF THE BALLOON KINKED. DURING PULLBACK OF THE BALLOON THE SHAFT FRACTURED PARTLY. THE BALLOON WAS COMPLETELY RECOVERED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466386 ↗
• MalfunctionAug 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10423540 ↗
• MalfunctionMar 25, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR DILATATION. THE DEVICE WAS ATTEMPTED TO BE REMOVED TO WIPE THE WIRE DOWN MORE; HOWEVER, THE DEVICE BECAME STUCK ON THE NON-BSC WIRE AND THE SHAFT BROKE IN HALF. BOTH DEVICES WERE COMPLETELY REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879890 ↗
• InjuryNov 7, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION #1 WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A NON-BSC WIRE CROSSED THE LESION, A STENT WAS PLACED AND A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR POST-DILATATION AT 4 SEPARATE INFLATIONS HELD FOR 16 SECONDS AT 22 ATMOSPHERES EACH. THE TARGET LESION #2 WAS A 15MM IN LENGTH LESION LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS CIRCUMFLEX ARTERY. A 2.5X16 SYNERGY WAS DEPLOYED INTO THE LESION AND THE SAME 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR POST-DILATATION. THE BALLOON WAS INFLATED AT 18 ATMOSPHERES FOR A BRIEF TIME AND THEN TRIED TO DEFLATE. HOWEVER, THE BALLOON WOULD NOT DEFLATE. PULLING A NEGATIVE PRESSURE ON THE ENCORE INFLATION DEVICE 5-8 TIMES WAS ATTEMPTED, BUT FAILED. THE ENCORE WAS DISCONNECTED AND A 20CC DRY SYRINGE WAS UTILIZED, BUT STILL NOTHING WOULD DEFLATE THE BALLOON. THE BACK END OF A 300CM LONG NON-BSC WIRE WAS INSERTED INTO A NON-BSC MICROGUIDE CATHETER IN AN ATTEMPT TO "POP" THE NC QUANTUM APEX BALLOON, HOWEVER THAT DID NOT WORK EITHER. THE PHYSICIAN THEN PULLED "REALLY HARD" ON THE BALLOON WHICH DISLODGED IT FROM THE STE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291178 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, 36MM IN LENGTH, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, NON-CALCIFIED, 3MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER A 3.5 6F EXTRA BACK-UP (EBU) GUIDE CATHETER ENGAGED THE LAD AND WAS CO AXIALLY WIRED WITH A NON-BSC GUIDE WIRE, THE LESION WAS PRE-DILATED WITH 2.5 X 9 MAVERICK BALLOON CATHETER LEAVING 60% RESIDUAL STENOSIS. A 38 X 3.00 PROMUS PREMIER DRUG-ELUTING STENT WAS DEPLOYED; HOWEVER, FOLLOWING POST-DILATATION WITH NC QUANTUM APEX BALLOON CATHETER, A STENT EDGE DISSECTION IN PROXIMAL END WAS NOTED. THE DISSECTION PART WAS THEN COVERED WITH ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 8267959 ↗
• MalfunctionMar 20, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAKAGE OCCURRED. DURING PREPARATION OF A 3.00X12MM NC QUANTUM APEX MR BALLOON CATHETER OUTSIDE THE PATIENT, THE BALLOON CATHETER WAS BROKEN ON THE DISTAL END WHILE THREADING THROUGH A GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6416674 ↗