NC Quantum Apex™ H7493912420320Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729783497), received between Jun 17, 2019 and Dec 14, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• InjuryDec 14, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 20MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. BALLOON WAS INTACT AND FINE WHEN IT WAS OPENED FROM THE PACKAGE. HOWEVER, UPON INFLATION, IT WAS FRACTURED IN THE MIDDLE OF THE WIRE AND COMPLETELY BROKE OFF FROM THE SYSTEM. THE BALLOON WAS ABLE TO BE RETRIEVED FROM THE BODY WITH A GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006535 ↗
• MalfunctionSep 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 20MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519227 ↗
• MalfunctionFeb 26, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 20MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR DILATION. THEY PULLED THE DEVICE OUT OF THE HOOP; HOWEVER, WHILE LOADING IT ONTO THE GUIDEWIRE, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759077 ↗
• MalfunctionJun 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. FOLLOWING STENT PLACEMENT, A 20 MM X 3.25 MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. ANOTHER 3.25 MM X 30 MM QUANTUM APEX BALLOON CATHETER WAS ADVANCED AND DILATED THE LESION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705871 ↗