NC Quantum Apex™ H7493912415200Recalls & reported problems
Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2
All models of NC Quantum Apex (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729783336), received between Oct 22, 2020 and Oct 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2024Leak/Splash; Leak/Splash
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-SEP-2024. IT WAS REPORTED THAT SHAFT LEAK WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH A 15 MM X 2.00 MM NC QUANTUM APEX BALLOON CATHETER, AND WHILE INFLATING, THE BALLOON STARTED LEAKING CONTRAST AT 4 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20486929 ↗MalfunctionOct 22, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 15MM X 2.00MM NC QUANTUM APEX MR WAS ADVANCED TO THE TARGET LESION, BUT THE BALLOON BURST INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10722007 ↗
Other Catheters, transluminal coronary angioplasty, percutaneous devices
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- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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