NC Quantum Apex™ H7493912412220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729783237), received between Dec 7, 2018 and Nov 18, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, DURING UNPACKING, THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825643 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS OPENED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10720433 ↗
• MalfunctionJun 25, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS USED, HOWEVER THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10195980 ↗
• MalfunctionSep 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 12MMX2.25MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9008575 ↗
• MalfunctionAug 14, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 92% STENOSED, 29MMX4.00MM, CONCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN ARTERY. A 12MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO POST-DILATE A 2.5X32 UNKNOWN STENT. HOWEVER, THE PHYSICIAN NOTICED THAT THE BALLOON SHAFT WAS BROKEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8894452 ↗
• MalfunctionDec 7, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF AN 12MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER, THE PHYSICIAN TRIED TO INSERT THE DEVICE INTO THE GUIDE CATHETER. WHILE ADVANCING THE SHAFT GOT BROKE OUTSIDE THE PATIENT BODY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8143445 ↗