NC Quantum Apex™ H7493912408300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729783152), received between Nov 14, 2018 and Nov 14, 2025 — classified as 1 death, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionNov 14, 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 22-OCT-2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. AN 8MM X 3.00MM NC QUANTUM APEX BALLOON WAS SELECTED FOR USE. HOWEVER, IT DID NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554969 ↗
• MalfunctionMar 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN 8MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961254 ↗
• MalfunctionJul 26, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF AN 8MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A 3MMX8MM NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103929 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY (LCX) AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS PREDILATED USING A 3.00 MM X 8 MM NC QUANTUM APEX BALLOON WITH 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. FOLLOWING PRE-DILATION, THE LESION WAS SUCCESSFULLY TREATED WITH A 3.00 MM X 8 MM STUDY DEVICE WITH 0% RESIDUAL STENOSIS. POST DILATION WAS NOT PERFORMED. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH A DISTAL EDGE DISSECTION AT THE DISTAL LCX. THE DISSECTION WAS TREATED WITH ANGIOPLASTY USING A 3.0 X 15 MM NON-BOSTON SCIENTIFIC DRUG ELUTING STENT. THE EVENT WAS CONSIDERED TO BE RECOVERED / RESOLVED.

  Patient problems: Vascular Dissection

  MAUDE report 13604771 ↗
• MalfunctionOct 6, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 8MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. DURING INSERTION OF THE CATHETER THROUGH THE HEMOSTATIC VALVE THE CATHETER SHAFT BROKE WHILE OUTSIDE THE PATIENT BODY. THE NC QUANTUM APEX BALLOON CATHETER WAS EXCHANGED FOR ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT CONDITION WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587204 ↗
• MalfunctionJan 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED DURING PREPARATION OF A 8MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON WAS NOT GOING NEGATIVE AND AS CONTRAST WAS PUSHED THROUGH, A HOLE WAS PRESENT IN THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11151262 ↗
• MalfunctionSep 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL ANTERIOR DESCENDING ARTERY. A 8MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING SECOND INFLATION AT 16 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541451 ↗
• MalfunctionDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26NOV2019. A 8MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS RECEIVED WITH NO ISSUES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON TORN LONGITUDINAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9438028 ↗
• InjuryJun 5, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). A 8MM X 3.0MM NC QUANTUM APEX WAS USED TO DILATE THE TARGET LESION. THE BALLOON WAS INFLATED TO 20 ATMOSPHERES ON THE FIRST INFLATION AND DURING THE SECOND INFLATION AT 22 ATMOSPHERES, THE BALLOON LOST ALL PRESSURE. DURING WITHDRAWAL OF THE BALLOON, THE CATHETER BROKE AT THE DISTAL END, APPROXIMATELY 15CM FROM THE TIP. AT FIRST, ONLY THE CATHETER WAS RETRIEVABLE WITHOUT THE BALLOON. A TRAPPING TECHNIQUE WAS THEN PERFORMED TO RETRIEVE THE BALLOON AND THE TIP OF THE CATHETER. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670113 ↗
• DeathNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 3.5X20MM, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). THE LESION CONTAINED A >45 AND <90 LESION BEND. FOLLOWING PREDILATION TWO NON BSC STENTS WERE IMPLANTED IN LCX AND THIS 8MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR POST DILATATION. HOWEVER, POST PROCEDURE WHEN THE PATIENT WAS SHIFTED TO CORONARY CARE UNIT AND EXPIRED. THE OFFICIAL CAUSE OF DEATH IS UNKNOWN AS NO AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 8069388 ↗