NC Quantum Apex™ H7493912415320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729783381), received between Oct 11, 2018 and Jun 22, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 15MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INITIAL INFLATION AT 11 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184876 ↗
• MalfunctionMay 13, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED VIA MEDWATCH MW5100714 THAT A SHAFT BREAK OCCURRED. A 15MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT CROSS INTO STENT AND THE DEVICE BROKE INTO TO SEPARATE PIECES. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11822353 ↗
• MalfunctionMay 3, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 15MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT FAILED TO CROSS INTO THE STENT. HOWEVER, UPON REMOVAL, THE DEVICE CAME APART INTO TWO SEPARATE PIECES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11767769 ↗
• MalfunctionApr 12, 2021Break

  BALLOON WOULD NOT CROSS INTO STENT, WAS REMOVED. DURING REMOVAL, THE DEVICE CAME APART (BROKE) INTO TWO SEPARATE PIECES. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11655278 ↗
• MalfunctionJul 2, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURED. THE PROCEDURE WAS INDICATED DUE TO ST SEGMENT MYOCARDIAL INFARCTION (STEMI). A 15MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO POST-DILATE A STENT N THE PROXIMAL PORTION OF THE VESSEL. HOWEVER, DURING DEFLATION, IT WAS NOTED THAT THE BALLON WAS UNABLE TO DEFLATE USING THE INDEFLATOR. A NEW INDEFLATOR AND STOPCOCK WERE ATTACHED TO THE BALLOON CATHETER BUT STILL FAILED TO DEFLATE THE BALLOON AGAIN. THE PHYSICIAN WAS ABLE TO PULL THE BALLOON INTO THE GUIDE CATHETER AND REMOVE IT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752439 ↗
• MalfunctionOct 11, 2018Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN OSTIAL CIRCUMFLEX ARTERY. A 15MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN REMOVAL WAS ATTEMPTED, IT WAS NOTED THAT THE DEVICE BECAME STUCK. THE PHYSICIAN PULLED THE DEVICE AND SPLIT THE BALLOON IN HALF. THE DEVICE WAS REMOVED BUT THE BROKEN PORTION REMAINED IN THE BODY. THE GUIDE WIRE WAS THEN PULLED OUT AND LUCKILY, THE BROKEN PORTION CAME OUT ALONG WITH IT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7955682 ↗