NC TREK NEO™ 1400250-25Recalls & reported problems
Abbott Vascular Inc. · NC TREK NEO™ Coronary Dilatation Catheter 2.50 X 25 mm / Rapid-Exchange · Class 2
All models of NC TREK NEO (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648232435), received between Mar 26, 2025 and Mar 12, 2026 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Difficult to Advance1
- Material Separation1
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2026Off-Label Use; Material Rupture; Material Separation; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT DISTAL ANASTOMOSIS OF LEFT FEMORAL POPLITEAL BYPASS GRAFT WITH HEAVY CALCIFICATION. THE 2.5X25MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. WHEN REMOVING THE BDC THE BALLOON SEPARATED AND REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 24584535 ↗MalfunctionMar 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. THE 2.5X25 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS INFLATED AND IT WAS NOTED THAT THE BALLOON WAS PERFORATED [RUPTURED]. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701971 ↗
Other Catheters, transluminal coronary angioplasty, percutaneous devices
- MINI TREK™ 1012270-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous223 reports
- 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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