NC Quantum Apex™ H7493912408250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729783138), received between Nov 8, 2018 and May 26, 2026 — classified as 5 malfunctions.

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

• MalfunctionMay 26, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-MAY-2026. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. AFTER 2.00MM AND 2.25 MM NC QUANTUM APEX BALLOON CATHETERS CROSSED THE LESION, A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER FAILED TO CROSS. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25293223 ↗
• MalfunctionMar 25, 2025Contamination; Nonstandard Device; Device Contamination with Chemical or Other Material; Contamination; Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE WAS CONTAMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689526 ↗
• MalfunctionSep 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 12-13 ATMOSPHERES FOR 2-3 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15365992 ↗
• MalfunctionMay 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED OBTUSE MARGINAL ARTERY. A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM) FOR 2 SECONDS, THE BALLOON RUPTURED. SUBSEQUENTLY, A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING THE FIRST INFLATION AT 8 ATM FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14323678 ↗
• MalfunctionNov 8, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY. AFTER A 190CM SAMURAI GUIDE WIRE WAS CROSSED THE LESION, A 8MM X 2.50MM NC QUANTUM APEX WAS ADVANCED FOR POST-DILATION. HOWEVER, IT WAS NOTED THAT THE GUIDE WIRE BECAME STUCK WITH THE BALLOON CATHETER. THE WIRE AND THE BALLOON WERE REMOVED TOGETHER. THEN THE PHYSICIAN AND SCRUB TECH TRIED TO REMOVED THE BALLOON FROM THE WIRE OUT SIDE THE PATIENT'S BODY BUT IT COULD NOT REMOVED EVEN GREAT FORCE WAS APPLY, AFTER SEVERAL ATTEMPT THE WIRE BASICALLY BROKE AT SOME POINT IN THE MONORAIL SEGMENT OF THE BALLOON WHERE IT WAS STUCK AND STARTED TO UNRAVEL. THE PROCEDURE WAS COMPLETED WITH A MARVEL GUIDE WIRE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER WITH THE SAMURAI GUIDEWIRE FOR THE RELATED COMPLAINT IN THE SHAFT. THE SHAFT, HYPOTUBE, TIP AND BALLOON WERE MICROSCOPICALLY AND VISUALLY EXAMINED. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS LOOSELY FOLDED. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE AND SHAFT. THE WIRE WAS STRETCHED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051363 ↗