NC Quantum Apex™ H7493912415250Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729783350), received between Mar 11, 2019 and Sep 21, 2026 — classified as 2 injuries, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848192 ↗
• MalfunctionDec 29, 2024Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19DEC2024. IT WAS REPORTED THAT BALLOON DAMAGED OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE TRYING TO CROSS THE CALCIFIC TARGET LESION, THE BALLOON GOT DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON HAD A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032587 ↗
• InjurySep 22, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE AND AIR EMBOLISM OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 15MM X 2.50MM NC QUANTUM BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS POSITIONED AT THE SITE OF THE LESION, AND WHEN ATTEMPTED TO BRING THE BALLOON TO A NEUTRAL STATE BY PULLING NEGATIVE ON THE INDEFLATOR, IT DID NOT GO NEUTRAL WHILE PREPARING TO INFLATE THE BALLOON. ANOTHER ATTEMPT TO INFLATE THE BALLOON WAS PERFORMED AND IT WAS DISCOVERED THAT AIR HAD ENTERED THE ARTERY, AND THE PATIENT BEGAN TO EXPERIENCE DECOMPENSATION. MEDICATIONS AND CARDIOPULMONARY RESUSCITATION (CPR) WERE ADMINISTERED TO STABILIZE THE PATIENT. IT WAS DETERMINED THAT AIR HAD BEEN INJECTED INTO THE CORONARY ARTERY DUE TO A HOLE IN THE BALLOON SHAFT AT THE MONORAIL PORT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION HAS FULLY RECOVERED.

  Patient problems: Air Embolism

  MAUDE report 17801319 ↗
• MalfunctionAug 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX CORONARY ARTERY. A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 7 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498707 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE SHAFT GOT SEPARATED. THE PORTION OF THE DEVICE WAS OUTSIDE OF THE BODY AT THE TIME OF THE FRACTURE. THE DEVICE WAS PULLED AND REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981779 ↗
• MalfunctionNov 18, 2021Break; Break

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT SHAFT BREAK OCCURRED. A LEFT HEART CATHERIZATION PROCEDURE WAS BEING PERFORMED. THIS 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE ADVANCING THE BALLOON, THE SHAFT BROKE IN TWO. THE BALLOON WAS REMOVED FROM THE PATIENT WITH NO DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841207 ↗
• MalfunctionNov 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH SEVERE MULTIFOCAL RESTENOSIS IN A LARGE POSTERIOR VENTRICULAR BRANCH, WHICH PRESENTED ACCENTUATED TORTUOSITY. A GUIDEZILLA CATHETER WAS INSERTED IN THE PROXIMAL THIRD OF THE POSTERIOR VENTRICULAR ARTERY. A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790654 ↗
• MalfunctionJun 8, 2021Contamination; Contamination

  IT WAS REPORTED THAT DEVICE WAS CONTAMINATED. A 15MM X 2.50MM NC QUANTUM APEX WAS SELECTED FOR USE. HOWEVER, THE DEVICE WAS CONTAMINATED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963303 ↗
• MalfunctionMay 3, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. WHILE ADVANCING A 15MM X 2.50MM NC QANTEM APEX IN A COMPLEX LESION, THE SHAFT BROKE. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579477 ↗
• MalfunctionApr 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 18 PSI, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8559563 ↗
• MalfunctionMar 11, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO BE INFLATED AND A HOLE WAS SUSPECTED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. A 15MMX2.50MM NC QUANTUM APEX BALLOON WAS UNABLE TO BE INFLATED AND THE USER SUSPECTED IT HAD A HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408591 ↗