TREKRecalls & reported problems across all models
Abbott Vascular Inc. · 50 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 909
- Deaths reported
- 10
- Injuries reported
- 148
- Recalls
- 0
We found 50 models of TREK by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 909 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2016 and Sep 30, 2026 — classified as 10 deaths, 148 injuries, 751 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (465 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TREK problems
Device problems
- Material Rupture465
- Material Separation225
- Difficult to Advance201
- Difficult to Remove194
- Improper or Incorrect Procedure or Method160
- Deflation Problem84
- Inflation Problem58
- Failure to Advance43
Patient problems
- No Clinical Signs, Symptoms or Conditions463
- No Consequences Or Impact To Patient300
- No Patient Involvement29
- Foreign Body In Patient22
- Air Embolism15
- Cardiac Arrest13
- Low Blood Pressure/ Hypotension12
- Device Embedded In Tissue or Plaque11
TREK models
50 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TREK™ 1012272-15Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- TREK™ 1012274-15Catheters, transluminal coronary angioplasty, percutaneous107 reports
- TREK™ 1012272-12Catheters, transluminal coronary angioplasty, percutaneous100 reports
- TREK™ 1012272-20Catheters, transluminal coronary angioplasty, percutaneous52 reports
- TREK™ 1012276-15Catheters, transluminal coronary angioplasty, percutaneous52 reports
- TREK™ 1012271-15Catheters, transluminal coronary angioplasty, percutaneous50 reports
- TREK™ 1012274-20Catheters, transluminal coronary angioplasty, percutaneous2 deaths40 reports
- TREK™ 1012274-12Catheters, transluminal coronary angioplasty, percutaneous1 death39 reports
- TREK™ 1012276-20Catheters, transluminal coronary angioplasty, percutaneous2 deaths36 reports
- TREK™ 1012280-15Catheters, transluminal coronary angioplasty, percutaneous24 reports
- TREK™ 1012274-30Catheters, transluminal coronary angioplasty, percutaneous2 deaths23 reports
- TREK™ 1012271-12Catheters, transluminal coronary angioplasty, percutaneous21 reports
- TREK™ 1012276-12Catheters, transluminal coronary angioplasty, percutaneous16 reports
- TREK™ 1012272-30Catheters, transluminal coronary angioplasty, percutaneous15 reports
- TREK™ 1012278-15Catheters, transluminal coronary angioplasty, percutaneous14 reports
- TREK™ 1012273-15Catheters, transluminal coronary angioplasty, percutaneous12 reports
- TREK™ 1012276-30Catheters, transluminal coronary angioplasty, percutaneous11 reports
- TREK™ 1012278-30Catheters, transluminal coronary angioplasty, percutaneous11 reports
- TREK™ 1012279-15Catheters, transluminal coronary angioplasty, percutaneous9 reports
- TREK™ 1012273-12Catheters, transluminal coronary angioplasty, percutaneous8 reports
- TREK™ 1012274-25Catheters, transluminal coronary angioplasty, percutaneous1 death8 reports
- TREK™ 1012280-12Catheters, transluminal coronary angioplasty, percutaneous8 reports
- TREK™ 1012271-20Catheters, transluminal coronary angioplasty, percutaneous7 reports
- TREK™ 1012274-08Catheters, transluminal coronary angioplasty, percutaneous7 reports
- TREK 1012405-12Catheters, transluminal coronary angioplasty, percutaneous7 reports
- TREK™ 1012273-20Catheters, transluminal coronary angioplasty, percutaneous6 reports
- TREK™ 1012275-15Catheters, transluminal coronary angioplasty, percutaneous6 reports
- TREK 1012405-15Catheters, transluminal coronary angioplasty, percutaneous6 reports
- TREK™ 1012272-08Catheters, transluminal coronary angioplasty, percutaneous5 reports
- TREK™ 1012275-12Catheters, transluminal coronary angioplasty, percutaneous5 reports
- TREK™ 1012278-12Catheters, transluminal coronary angioplasty, percutaneous5 reports
- TREK™ 1012279-12Catheters, transluminal coronary angioplasty, percutaneous5 reports
- TREK™ 1012271-08Catheters, transluminal coronary angioplasty, percutaneous4 reports
- TREK™ 1012272-25Catheters, transluminal coronary angioplasty, percutaneous4 reports
- TREK™ 1012278-20Catheters, transluminal coronary angioplasty, percutaneous4 reports
- TREK 1012405-20Catheters, transluminal coronary angioplasty, percutaneous4 reports
- TREK 1012405-08Catheters, transluminal coronary angioplasty, percutaneous3 reports
- TREK™ 1012276-25Catheters, transluminal coronary angioplasty, percutaneous2 reports
- TREK™ 1012278-08Catheters, transluminal coronary angioplasty, percutaneous2 reports
- TREK 1012404-20Catheters, transluminal coronary angioplasty, percutaneous2 reports
- TREK 1012405-06Catheters, transluminal coronary angioplasty, percutaneous2 reports
- TREK™ 1012275-20Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK™ 1012276-08Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK™ 1012277-12Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK™ 1012277-15Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK 1012404-08Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK 1012404-12Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK 1012406-15Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK 1012407-20Catheters, transluminal coronary angioplasty, percutaneous1 report
- TREK 1012409-15Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent TREK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949012 ↗MalfunctionSep 30, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948936 ↗MalfunctionAug 21, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379243 ↗MalfunctionJun 4, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING LESION WITH 99% STENOSIS. A 2.75X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION. HOWEVER, RESISTANCE WAS NOTED DURING ADVANCEMENT. DURING THE FIRST INFLATION AT 6 ATM, THE BALLOON RUPTURED. AN ADDITIONAL TREK BDC WAS USED TO COMPLETE THE PROCEDURE. 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 25395167 ↗MalfunctionJun 3, 2026Material Separation
IT WAS REPORTED THAT THE 3.0X15MM TREK BALLOON DILATATION CATHETER (BDC) SHAFT SEPARATED (JUST BELOW THE HUB) DURING PREPARATION, PRIOR TO BEING INSERTED IN THE ANATOMY. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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 25377166 ↗MalfunctionMay 22, 2026Material Separation
IT WAS REPORTED THAT THE PACKAGING OF THE 2.50X12MM TREK BALLOON DILATATION CATHETER WAS OPENED, THE PROXIMAL SHAFT WAS OBSERVED TO BE SEPARATED. A NEW 2.50X12MM TREK BDC WAS USED TO PERFORM PRE-DILATION. A NON-ABBOTT STENT WAS IMPLANTED AND A 2.50X20MM NC TREK NEO WAS USED TO PERFORM POST-DILATATION. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT WITH THE COMPLAINT DEVICE, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257692 ↗InjuryMay 21, 2026Material Rupture; Material Separation
MEDWATCH REPORT #MW5187393. TREK 3.0 X 15 ANGIOPLASTY BALLOON RUPTURED WITH PORTION OF BALLOON RETAINED, INTERVENTION REQUIRED TO MITIGATE PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 25240610 ↗InjuryMay 19, 2026Improper or Incorrect Procedure or Method; Failure to Deflate
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH 100% CONTRAST MIX. THEN THE BDC WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON WOULD NOT DEFLATE. THEREFORE, THE BALLOON HAD TO BE CUT AND REMOVED FROM THE WIRE. ANOTHER SAME SIZE TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25221446 ↗MalfunctionMay 19, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE 2.25X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE WITHOUT INCIDENT. THE BDC MET RESISTANCE WITH THE MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, WHEN IT WAS ADVANCED TO THE TARGET FOR PREDILATATION. THE BDC RUPTURED AT 6 ATMOSPHERES DURING ITS FIRST INFLATION. THE BDC WAS REMOVED. A 2.0X15 MM MINI TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT ADVERSE EVENTS, AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAYS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25217734 ↗MalfunctionMay 14, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X12MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 25173120 ↗MalfunctionMay 12, 2026Material Separation; Deformation Due to Compressive Stress
IT WAS REPORTED THAT PRIOR TO USE THE PROXIMAL SHAFT OF THE 2.5X12MM TREK BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE KINKED AND THE HUB SEPARATED FROM THE BDC DURING PREPARATION. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25156849 ↗MalfunctionMay 12, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 3.00X15MM TREK RX BALLOON DILATATION CATHETER, RESISTANCE WAS ENCOUNTERED AT THE LESION SITE. ONCE AT THE LESION, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. THE TREK BDC WAS WITHDRAWN, AND A NEW TREK BDC WAS USED TO COMPLETE THE PROCEDURE. 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 25150685 ↗MalfunctionMay 12, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2.25X15M TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT, AND ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. 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 25149918 ↗MalfunctionMay 12, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 2.25X20 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149004 ↗MalfunctionMay 8, 2026Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3X15 MM TREK BALLOON DILATATION CATHETER RUPTURED AT NOMINAL PRESSURE. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126051 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 recalls
- NC TREK56 models · 1,842 reports · 12 recalls
- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- XIENCE ALPINE72 models · 898 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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