MINI TREKRecalls & reported problems across all models
Abbott Vascular Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 669
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 25 models of MINI TREK by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 669 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2016 and Sep 30, 2026 — classified as 27 injuries, 642 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (456 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 MINI TREK problems
Device problems
- Material Rupture456
- Difficult to Advance247
- Difficult to Remove90
- Improper or Incorrect Procedure or Method82
- Material Separation68
- Failure to Advance46
- Inflation Problem41
- Leak/Splash32
Patient problems
- No Clinical Signs, Symptoms or Conditions444
- No Consequences Or Impact To Patient175
- No Patient Involvement23
- Insufficient Information8
- Intimal Dissection6
- Air Embolism5
- Angina4
- Non specific EKG/ECG Changes3
MINI TREK models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MINI TREK™ 1012270-15Catheters, transluminal coronary angioplasty, percutaneous223 reports
- MINI TREK™ 1012270-12Catheters, transluminal coronary angioplasty, percutaneous162 reports
- MINI TREK™ 1012270-20Catheters, transluminal coronary angioplasty, percutaneous55 reports
- MINI TREK™ 1012269-12Catheters, transluminal coronary angioplasty, percutaneous49 reports
- MINI TREK™ 1012269-15Catheters, transluminal coronary angioplasty, percutaneous43 reports
- MINI TREK™ 1012270-08Catheters, transluminal coronary angioplasty, percutaneous23 reports
- MINI TREK™ 1012270-30Catheters, transluminal coronary angioplasty, percutaneous16 reports
- MINI TREK™ 1012269-08Catheters, transluminal coronary angioplasty, percutaneous14 reports
- MINI TREK™ 1012403-08ACatheters, transluminal coronary angioplasty, percutaneous14 reports
- MINI TREK™ 1012269-06Catheters, transluminal coronary angioplasty, percutaneous13 reports
- MINI TREK™ 1012403-06ACatheters, transluminal coronary angioplasty, percutaneous11 reports
- MINI TREK™ 1012269-20Catheters, transluminal coronary angioplasty, percutaneous10 reports
- MINI TREK™ 1012402-08ACatheters, transluminal coronary angioplasty, percutaneous8 reports
- MINI TREK 1012268-12UCatheters, transluminal coronary angioplasty, percutaneous7 reports
- MINI TREK™ 1012402-15ACatheters, transluminal coronary angioplasty, percutaneous4 reports
- MINI TREK 1012268-08UCatheters, transluminal coronary angioplasty, percutaneous3 reports
- MINI TREK™ 1012402-06ACatheters, transluminal coronary angioplasty, percutaneous3 reports
- MINI TREK 1012268-06UCatheters, transluminal coronary angioplasty, percutaneous2 reports
- MINI TREK™ 1012402-20ACatheters, transluminal coronary angioplasty, percutaneous2 reports
- MINI TREK™ 1012403-12ACatheters, transluminal coronary angioplasty, percutaneous2 reports
- MINI TREK™ 1012270-25Catheters, transluminal coronary angioplasty, percutaneous1 report
- MINI TREK 1012268-15UCatheters, transluminal coronary angioplasty, percutaneous1 report
- MINI TREK 1012268-20UCatheters, transluminal coronary angioplasty, percutaneous1 report
- MINI TREK™ 1012402-12ACatheters, transluminal coronary angioplasty, percutaneous1 report
- MINI TREK™ 1012403-20ACatheters, transluminal coronary angioplasty, percutaneous1 report
Recent MINI 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, 2026Break; Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949580 ↗MalfunctionSep 30, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949013 ↗MalfunctionSep 25, 2026Material Rupture; Improper or Incorrect Procedure or Method
It was reported the procedure was to treat a mildly tortuous and severely calcified lesion in the mid Left Circumflex artery. The 2.0x20mm RX Mini Trek balloon dilatation catheter was not soaked during the preparation for use. The device was advanced to the target lesion however during inflation, the balloon ruptured due to severe calcification of the lesion. Th procedure was completed using another device. There were no adverse patient effects. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896585 ↗MalfunctionSep 24, 2026Material Rupture; Difficult to Advance
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous lesion in the left anterior descending artery with a 2.00x15mm MINI TREK RX balloon dilatation catheter (BDC). Reportedly, resistance was encountered at the lesion site when advancing the balloon to the target lesion. The balloon ruptured at 6 atmospheres during the first inflation. The BDC was removed from the patient. The procedure was continued using another TREK balloon. There were no adverse patient effects. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884994 ↗MalfunctionJun 2, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. 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 25363511 ↗MalfunctionMay 26, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.00X12MM MINI TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH THE LESION. ONCE AT THE LESION FOR PREDILATATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A 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 25279882 ↗MalfunctionMay 7, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. THE 2.0X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATM 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 25113767 ↗MalfunctionMay 6, 2026Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT MAIN CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, A 2X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES, (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT, AND ANOTHER TREK BDC 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 25104881 ↗MalfunctionApr 27, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.0X12MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING THE FIRST INFLATION AT 6 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 25001541 ↗MalfunctionApr 23, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATION, THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 24972043 ↗MalfunctionApr 16, 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 2.00X15MM MINI TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH THE LESION. ONCE AT THE LESION, THE MINI TREK BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. THE MINI TREK RX BDC WAS REMOVED, AND A NEW TREK 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 24899618 ↗MalfunctionApr 9, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS #3 CORONARY VESSEL THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.00X12MM MINI TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS ENCOUNTERED WITH THE LESION SITE. ONCE AT THE LESION FOR PRE-DILATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE INITIAL INFLATION. THE MINI TREK RX BDC WAS REMOVED, AND A NEW TREK 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 24832605 ↗MalfunctionApr 3, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.0X15MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING THE FIRST INFLATION AT 10 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 24778793 ↗MalfunctionApr 3, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT CIRCUMFLEX ARTERY. THE 1.50X12MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. 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 24778790 ↗MalfunctionApr 3, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 2.0X12MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. 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 24778737 ↗
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
- TREK50 models · 909 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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