NC Quantum Apex™ H7493912415400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729783411), received between Oct 17, 2018 and Feb 5, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN NC QUANTUM APEX 15 X 4.00MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. IT WAS DISCOVERED THAT THE BALLOON COULD NOT BE INFLATED AS THE BALLOON HAD ALREADY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272249 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT A DEVICE BROKE. DURING PREPARATION AND WHILE OUTSIDE THE PATIENT, A 15MM X 4.00MM NC QUANTUM APEX BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS FOUND TO BE BROKEN WHEN IT WAS TAKEN OUT OF THE BOX AND THE DEVICE WAS NOT USED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848781 ↗
• MalfunctionDec 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED DISTAL RIGHT CORONARY ARTERY. A 15MM X 4.00MM NC QUANTUM APEX CATHETERS WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200981 ↗
• MalfunctionOct 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 15MM X 4.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973747 ↗