NC Quantum Apex™ H7493912430350Recalls & 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 08714729783619), received between Nov 7, 2018 and Feb 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Difficult to Remove1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED VESSEL. A 30MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13455519 ↗MalfunctionNov 7, 2018Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility
IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 30MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR DILATATION. AFTER DEFLATING THE BALLOON, THE DEVICE WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE DEVICE DOES NOT SLIDE EASILY AND GOT STUCK WITH THE GUIDE. AFTER SEVERAL ATTEMPTS, THE DEVICE WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8048089 ↗
Other Catheters, transluminal coronary angioplasty, percutaneous devices
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- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- 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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