NC Quantum Apex™ H7493912420250Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729783466), received between Nov 29, 2018 and May 26, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 20MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 11 ATMOSPHERES FOR 4 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY 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 17011717 ↗
• MalfunctionOct 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (PAD). THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING. ROTABLATION WAS PERFORMED FIRST. A 20MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS THEN ADVANCED FOR DILATION AND WAS INFLATED TWICE AT 20 ATMOSPHERES FOR 20 SECONDS. HOWEVER, DURING THE THIRD INFLATION AT 20 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X20 NC QUANTUM APEX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571485 ↗
• MalfunctionOct 3, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 20MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER THE THIRD INFLATION AT 26 ATMOSPHERES, THE BALLOON HAD DIFFICULTY IN RETRACTING OFF THE NON-BSC WIRE. THE BALLOON WAS REMOVED FULLY DEFLATED 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 15528765 ↗
• MalfunctionMay 12, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT OF DEVICE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 20MM X 2.50MM NC QUANTUM APEX WAS ADVANCED FOR DILATATION AND INFLATED TO 20 ATMOSPHERES. HOWEVER, DURING THE PROCEDURE, THE DEVICE GOT STUCK ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BALLOON AND GUIDEWIRE WERE BOTH REMOVED FROM THE PATIENT'S BODY SIMULTANEOUSLY AS ONE UNIT. IT WAS NOTED THAT THE BALLOON WAS DEFLATED PRIOR TO REMOVAL AND WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14381192 ↗
• MalfunctionMay 4, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT FROZE ON WIRE WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 20MM X 2.50MM NC QUANTUM APEX WAS ADVANCED FOR DILATATION AND INFLATED TO 20 ATMOSPHERES FOR 20 SECONDS. HOWEVER, FOLLOWING DILATATION, THE DEVICE BECAME STUCK ON A 180 CM NON-BOSTON SCIENTIFIC GUIDEWIRE. THE PHYSICIAN TRIED TO PULL HARD ON THE BALLOON FROM THE WIRE. BOTH DEVICES WERE REMOVED FROM THE PATIENT AS ONE UNIT. IT WAS NOTED THAT THE BALLOON WAS FULLY DEFLATED PRIOR TO REMOVAL AND WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279679 ↗
• MalfunctionMay 4, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT OF DEVICE OCCURRED. THE TARGET LESION WAS LOCATED WITHIN THE CORONARY ARTERY. A NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE TO TREAT THE LESION. DURING THE PROCEDURE THE NC. QUANTUM APEX BALLOON WOULD BECOME STUCK TO THE NON-BSC GUIDEWIRE AFTER THE NC. QUANTUM APEX BALLOON WAS INFLATED TO 20 ATM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279487 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED DESCENDING ARTERY. DURING THE PROCEDURE, TWO 20MM X 2.50MM AND A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETERS WERE USED TO DILATE THE LESION. HOWEVER, DURING INFLATION AT LESS THAN 14 ATMOSPHERES, THE BALLOONS RUPTURED. THE DEVICES WERE REMOVED AND UPON CHECKING THE ARTERY, THE LESION WAS NOT DILATED. A ROTATIONAL ATHERECTOMY WITH A 1.75MM BALLOON WAS USED TO PREPARE THE ARTERY FOR STENT IMPLANTATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13699683 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED DESCENDING ARTERY. DURING THE PROCEDURE, TWO 20MM X 2.50MM AND A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETERS WERE USED TO DILATE THE LESION. HOWEVER, DURING INFLATION AT LESS THAN 14 ATMOSPHERES, THE BALLOONS RUPTURED. THE DEVICES WERE REMOVED AND UPON CHECKING THE ARTERY, THE LESION WAS NOT DILATED. A ROTATIONAL ATHERECTOMY WITH A 1.75MM BALLOON WAS USED TO PREPARE THE ARTERY FOR STENT IMPLANTATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13699489 ↗
• MalfunctionFeb 15, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 20MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS OBSERVED THAT DEVICE WAS FOLDED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535484 ↗
• MalfunctionSep 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 20MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. 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 12554301 ↗
• MalfunctionJul 17, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. DURING A PROCEDURE, THE 20MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS CAUGHT IN THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8800658 ↗
• MalfunctionNov 29, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH THAT BALLOON PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.5X20MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS ADVANCED OVER THE WIRE, THE WIRE DID NOT EXIT IN THE PROPER PLACE, INSTEAD IT EXITED THROUGH THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8115625 ↗