NC TREK 1012448-06Recalls & reported problems
Abbott Vascular Inc. · NC TREK Coronary Dilatation Catheter 2.75 mm x 6 mm / Rapid-Exchange · Class 2
All models of NC TREK (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648151798), received between Sep 2, 2016 and Sep 2, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient1
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2016Detachment Of Device Component; Insufficient Device Problem Information
THE 2.75 X 6 MM NC TREK BALLOON CATHETER WAS RECEIVED AT ABBOTT VASCULAR IN A BIOHAZARD BAG WITH NO INFORMATION. FOLLOW-UP WAS ATTEMPTED, BUT THE CATH LAB STATED THAT THEY WERE UNAWARE OF ANYTHING CONCERNING THIS DEVICE OR IT'S RETURN. RETURN DEVICE ANALYSIS REVEALED THE BALLOON CATHETER HAD BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN, INDICATING ITS USE IN THE PATIENT ANATOMY. THE DISTAL SHAFT WAS SEPARATED AND WAS NOT RETURNED. AS NO INFORMATION IS AVAILABLE REGARDING THE LOCATION OF THE DISTAL PORTION OF THE CATHETER, IT CANNOT BE CONFIRMED IF THE SEPARATION OCCURRED INSIDE THE PATIENT AND POSSIBLY REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Information
MAUDE report 5926755 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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