NC Quantum Apex™ H7493912415350Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729783398), received between May 1, 2019 and Mar 14, 2025 — classified as 1 death, 9 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.

• MalfunctionMar 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. PHYSICIAN PRE-DILATED WITH A 2.0 SC BALLOON THEN TOOK A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER. HOWEVER, THE BALLOON GOT BURST AT 11 ATMOSPHERES DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610213 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL/MID LEFT ANTERIOR DESCENDING ARTERY. A 15 MM X 3.50 MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE PART ALMOST CLOSE TO HALF WAY UP THE SHAFT WAS FRACTURED. ONLY THE PART OF THE DEVICE WAS IN THE PATIENT AND THE PART THAT BROKE WAS STILL OUTSIDE THE BODY AND WAS EASILY PULLED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254867 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE BALLOON BROKE OR CRACKED WHILE INSERTING INTO THE SHEATH. THE BALLOON WAS REMOVED AND COMPLETED THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976553 ↗
• DeathApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEATH OCCURRED. THE 80% STENOSED, ANGULATED, DE NOVO TARGET LESION WAS LOCATED IN THE TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS TREATED WITH DIRECT STENTING USING A 20 X 3.50 PROMUS PREMIER DRUG ELUTING STENT. POST DILATATION WAS PERFORMED WITH A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER. THE PROCEDURE WAS COMPLETED AND THE PATIENT STATUS WAS STABLE. HOWEVER, POST-PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN, PALPITATION, BACK PAIN, CARDIOGENIC SHOCK, AND CARDIAC ARREST. ELECTROCARDIOGRAM CHANGES WERE NOTED AND ACUTE STENT THROMBOSIS WAS SUSPECTED. ENOXAPARIN WAS GIVEN TO THE PATIENT TO TREAT THE THROMBOSIS. THE PATIENT EXPIRED AT NIGHT POST-PROCEDURE. THE OFFICIAL CAUSE OF DEATH WAS ACUTE STENT THROMBOSIS. IT WAS THOUGHT THAT A POSSIBLE PROXIMAL DISSECTION CONTRIBUTED TO THE DEVELOPMENT OF THE THROMBOSIS. NO AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Arrest; Vascular Dissection

  MAUDE report 11754098 ↗
• MalfunctionNov 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON MATERIAL RUPTURE OCCURRED. A 15MM X 3.50MM NC QUANTUM APEX BALLOON WAS ADVANCED TO THE TARGET LESION. AN ATTEMPT TO INFLATE THE BALLOON WAS MADE, BUT THE BALLOON WOULD NOT FULLY INFLATE. THE DEVICE WAS VIEWED UNDER X RAY AND IT WAS NOTICED THAT A HOLE IN THE BALLOON OCCURRED, AND THE WHOLE FRONT OF THE BALLOON ITSELF WAS A HOLE. THE BALLOON WAS DEFLATED TWICE AND REMOVED FROM THE PATIENT. AFTER THE BALLOON WAS REMOVED, IT WAS NOTICED THAT BALLOON WAS PARTIALLY INFLATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

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

  MAUDE report 10884807 ↗
• MalfunctionNov 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING THE PROCEDURE, 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10803596 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER A GUIDE CATHETER CROSSED THE LESION, A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, PRIOR TO EXITING THE DISTAL PORTION OF THE GUIDE, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10614588 ↗
• MalfunctionMar 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. A 15MM X 3.50MM NC QUANTUM APEX BALLOON WAS ADVANCED TO THE TARGET LESION, AND AFTER INFLATION THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9880147 ↗
• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. THE DEVICE WAS COMPLETELY REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9577519 ↗
• MalfunctionMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. THIS DEVICE WAS RECEIVED WITH NO REPORTED ISSUES. HOWEVER, DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569703 ↗