TREK 1012409-15Recalls & reported problems
Abbott Vascular Inc. · TREK Coronary Dilatation Catheter 3.50 mm x 15 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 08717648154263), received between Aug 26, 2022 and Aug 26, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Difficult to Remove1
- 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 26, 2022Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT PRIOR TO USE ON BOTH BALLOONS THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH, THE CATHETERS WERE SOAKED IN SALINE AND BOTH BDCS WERE PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THE PROCEDURE WAS TO TREAT A RESTENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.50X15MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITH DIFFICULTY DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED TWO TIMES TO 14 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED AT 14 ATM. THE BDC WAS REMOVED FROM THE PATIENT WITH DIFFICULTY DUE TO THE ANATOMY. THEN, A 4.00X15MM TREK BDC WAS ADVANCE WITH DIFFICULTY DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED ALSO TO 14 ATM TWICE; HOWEVER, THE SECOND BALLOON ALSO RUPTURED AT 14 ATM. THE BDC WAS REMOVED FROM THE PATIENT WITH RESISTANCE NOTED DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15306622 ↗
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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