TREK 1012404-12Recalls & reported problems
Abbott Vascular Inc. · TREK Coronary Dilatation Catheter 2.25 mm x 12 mm / Over-The-Wire · Class 2
All models of TREK (50)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648153907), received between Aug 24, 2021 and Aug 24, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE DIAGONAL ARTERY. THE 2.25X12MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM), IT WAS NOTICED THAT THE BALLOON DID NOT APPEAR TO BE FULLY INFLATING. NEGATIVE PRESSURE WAS APPLIED, AND DURING THE SECOND INFLATION AT 8 ATM, THE BALLOON STILL DID NOT APPEAR TO BE FULLY INFLATING. THE BDC WAS THEN REMOVED AND TESTED OUTSIDE THE PATIENT. A SMALL PINHOLE WAS OBSERVED ON THE DISTAL END OF THE BALLOON AND AIR WAS COMING OUT. THE PATIENT DID NOT NEED TO BE RE-BALLOONED AS THE TREK WAS ABLE TO DILATE THE LESION DESPITE THE BALLOON NOT FULLY INFLATING. THE TARGET LESION WAS TREATED, AND THE PATIENT REMAINED STABLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12363080 ↗
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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