NC Quantum Apex™ H7493912415300Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729783374), received between Jan 10, 2017 and Jul 15, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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.

• MalfunctionJul 15, 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 10-JUL-2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513207 ↗
• MalfunctionMar 18, 2024Material 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 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 4 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923953 ↗
• MalfunctionOct 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE BALLOON RUPTURED WHEN IT WAS INFLATED TO 20 ATMOSPHERES. THE DEVICE WAS REMOVED AND REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927500 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 97% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY TO LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POS-DILATATION. HOWEVER, DURING INFLATION, THE SHAFT WAS BROKEN. THE DEVICE WAS PULLED OUT AND COMPLETELY REMOVED FROM THE PATIENT'S BODY. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028227 ↗
• InjuryApr 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED WITH ANGINA FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY IN THE RIGHT CORONARY ARTERY (RCA). THE 70% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED RCA. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON DISTALLY INFLATED INSIDE THE BODY AT 12 ATMOSPHERES IN FIRST ATTEMPT, AND THE BALLOON SHAFT INFLATED LEADING TO A FLOW LIMITING TYPE A DISSECTION IN THE OSTIO PROXIMAL RCA. A CHEST PAIN OCCURRED RELATED TO THE DISSECTION. A STENT WAS DEPLOYED TO COVER THE DISSECTION, TREATED WITH A GRAFT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FURTHER PATIENT COMPLICATIONS, AND THE PATIENT WAS STABILIZED IN THE ICCU (INTENSIVE CORONARY CARE UNIT) POST PROCEDURE.

  Patient problems: Chest Pain; Reduced Blood Flow; Vascular Dissection

  MAUDE report 16733063 ↗
• MalfunctionMar 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, AS THE BALLOON WAS BEING OPENED, THE CATHETER RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865551 ↗
• MalfunctionDec 28, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CATHETER SHAFT BREAK OCCURRED. A 15MM X 3.00MM NC QUANTUM APEX WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. IT WAS NOTED THAT THE CATHETER OF THE NC QUANTUM APEX BROKE WITHOUT ANY STRESS OR PRESSURE TO THE SHAFT. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13098723 ↗
• MalfunctionOct 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. ASPIRATION OF THE BALLOON THAT WAS INSIDE THE CATHETER WAS PERFORMED. HOWEVER, WHEN THE BALLOON SYSTEM WAS REMOVED, IT WAS NOTICED THAT THERE WAS AVULSION AT THE DISTAL PORTION OF THE SYSTEM. THE DISTAL PORTION WAS FOUND INSIDE THE GUIDE CATHETER, AND CAN BE REMOVED WITHOUT CONSEQUENCES FOR THE PATIENT. NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10697410 ↗
• MalfunctionMay 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED, 32MMX3MM, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER CROSSING THE LESION WITH A NON-BSC GUIDE WIRE, A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND PRE-DILATATION WAS PERFORMED WITH A 3.00X12MM NC QUANTUM APEX BALLOON CATHETER. A 3.00X32MM PROMUS PREMIER SELECT STENT STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATONS WERE REPORTED. THE PATIENT WAS STABLE AND RESPONDING WELL TO MEDICINES. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE SECOND INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088524 ↗
• MalfunctionApr 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED, 16MM X 3.00MM, CONCENTRIC, DE NOVO TARGET LESION WITH A SIGNIFICANT BEND OF <=45 DEGREES WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED DUE TO CALCIFICATION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING INITIAL INFLATION AT 16 ATMOSPHERES FOR 15 SECONDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009706 ↗
• MalfunctionMar 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THERE WAS A HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9819755 ↗
• MalfunctionDec 30, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, AFTER THE BALLOON WAS DEFLATED, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, BUT IT BECAME STUCK WITH THE WIRE. THE PHYSICIAN THEN DECIDED TO REMOVE THE WHOLE SYSTEM AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9531462 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A DIAGONAL LESION OF A CORONARY ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS INSERTED BUT THE BALLOON WAS NOT EXITING THE GUIDE CATHETER. WHEN THE DEVICE WAS TOOK OUT, IT WAS NOTICED THAT THE HYPOTUBE WAS BROKEN. PHYSICIAN USED A NEW GUIDE AND WIRE AND CONTINUED THE INTERVENTION WITHOUT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216463 ↗
• MalfunctionJul 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FOURTH INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SMOOTHLY AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831437 ↗
• MalfunctionJun 27, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-JUN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED >45 AND < 90 DEGREES BEND. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO CALCIFICATION AND HIGHLY FIBROSIS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739186 ↗
• MalfunctionMar 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION AS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO BE DELIVERED. WHEN IT WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTICED THAT THE PROXIMAL EDGE OF THE STENT STRUTS WERE DAMAGED. ANOTHER STENT OF THE SAME SIZED WAS ADVANCED TO THE LESION. SUBSEQUENTLY, A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT IT FAILED TO CROSS THE LESION. ANOTHER 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PHYSICIAN GRABBED ANOTHER BALLOON AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429519 ↗
• MalfunctionApr 24, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CIRCUMFLEX ARTERY. A 3.00 X 15 MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED THROUGH GUIDEWIRE WITHOUT DIFFICULTY. BEFORE THE DEVICE ENTERED INTO THE PATIENT, THE SHAFT BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6515620 ↗
• MalfunctionJan 10, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA). A 3.00X15MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED TO THE LESION. AFTER DILATION WITH 22 BAR, THE BALLOON CATHETER WAS ATTEMPTED TO BE REMOVED, BUT IT ENTRAPPED ON THE GUIDEWIRE. BOTH DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6239503 ↗