MINI TREK™ 1012269-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648138072), received between Dec 16, 2016 and Nov 13, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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, 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO MODERATELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 75% STENOSED. DURING ADVANCEMENT OF A 1.50X6MM MINI TREK BALLOON DILATATION CATHETER, RESISTANCE WAS FELT DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE MINI TREK BALLOON WAS INFLATED TWICE AT 8 ATMOSPHERES; HOWEVER RUPTURED DURING THE THIRD INFLATION AT 12 ATMOSPHERES. A 1.5X10MM NON-ABBOTT BALLOON WAS USED TO DILATE THE LESION. 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 23548278 ↗
• MalfunctionJul 23, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 1.50X6MM MINI TREK BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH ANATOMY. ONCE AT THE LESION DURING PRE-DILATION, THE MINI TREK BALLOON RUPTURED ON THE FIRST INFLATION AT 14 ATMOSPHERES. A 1.50X6MM 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 22580640 ↗
• MalfunctionJun 18, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY THAT IS 90% STENOSED. A 1.5X6MM MINI TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS FELT WITH ANATOMY. DURING THE FIRST INFLATION AT 7 ATMOSPHERES THE BALLOON RUPTURED. THE PROCEDURE WAS CONTINUED WITH ANOTHER TREK BALLOON. THERE WAS 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 22288278 ↗
• MalfunctionMay 2, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 1.50X6MM MINI TREK BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH ANATOMY. ONCE AT THE LESION, THE MINI TREK BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. THE MINI TREK BDC WAS WITHDRAWN, AND A NEW NC TREK 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 21952083 ↗
• MalfunctionDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). A 1.50X6MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR VESSEL DILATION; HOWEVER, THE BALLOON WAS NOTED TO RUPTURE AT 8ATM DURING THE FIRST INFLATION. THE BDC WAS REMOVED AND REPLACED WITH A NEW TREK BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21038062 ↗
• MalfunctionFeb 26, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 1.5X6MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND A 1.2X6MM MINI TREK BDC WAS ADVANCED ALSO WITH RESISTANCE; HOWEVER, THE SECOND MINI TREK BALLOON ALSO RUPTURED AT 6 ATM DURING THE FIRST INFLATION. THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT CUTTING BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784976 ↗
• MalfunctionJan 16, 2024Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  SUBSEQUENTLY, AFTER THE DEVICE WAS ANALYZED IT WAS NOTED THAT THE TIP WAS TORN. IT WAS CONFIRMED THE TIP BECAME SMASHED AND TORN DURING PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519739 ↗
• MalfunctionDec 8, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. THE TREK RX MET RESISTANCE DURING ADVANCEMENT AND DID NOT CROSS THE HEAVILY CALCIFIED LESION. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL. A NON-ABBOTT BALLOON WAS USED TO CROSS AND DILATE THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293434 ↗
• MalfunctionSep 27, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS, 100% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 1.5X6MM MINI TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS DUE TO THE ANATOMY AND FACED RESISTANCE WITH THE ANATOMY DURING REMOVAL. A NON-ABBOTT BALLOON AND AN UNSPECIFIED STENT WERE USED TO SUCCESSFULLY 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 12533689 ↗
• MalfunctionMay 18, 2020Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.50X6MM MINI TREK BALLOON DILATATION CATHETER (BDC), WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THERE WAS RESISTANCE WITH THE LESION NOTED DURING REMOVAL OF THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067586 ↗
• MalfunctionMar 26, 2018Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 100% STENOSED, MILDLY TORTUOUS, AND HEAVILY CALCIFIED CONCENTRIC LESION IN THE DISTAL RIGHT CORONARY ARTERY. RESISTANCE WITH THE LESION WAS FELT WHEN ADVANCING A 1.50X6MM MINI TREK BALLOON DILATATION CATHETER (BDC) AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE BDC WAS REPLACED WITH ANOTHER SEMI-COMPLIANT BALLOON TO INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER TREATMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372025 ↗
• MalfunctionFeb 21, 2018Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, AND DE NOVO MID RIGHT CORONARY ARTERY THAT WAS 100% STENOSED. AN UNSPECIFIED GUIDEWIRE ADVANCED TO THE LESION, BUT A 1.5 X 6 MM RX MINI TREK BALLOON CATHETER MET RESISTANCE DURING ADVANCEMENT AND COULD NOT CROSS DUE TO THE ANATOMY. THE MINI TREK BALLOON CATHETER WAS REMOVED WITH RESISTANCE AND REPLACED WITH A NON-ABBOTT BALLOON CATHETER. THEN THE LESION WAS PRE-DILATATED WITH A NON-ABBOTT BALLOON, AND A 3.25 X 15 MM NC TREK BALLOON WAS USED FOR FURTHER DILATATION. THE NC TREK BALLOON MET RESISTANCE DURING ADVANCEMENT DUE TO THE ANATOMY, BUT REACHED THE TARGET LESION AND DURING FIRST INFLATION THE NC TREK BALLOON RUPTURED AT 10 ATMOSPHERES. THE NC TREK BALLOON WAS REMOVED WITH RESISTANCE DUE TO THE ANATOMY. A ROTABLATOR AND AN UNSPECIFIED XIENCE STENT WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286484 ↗
• MalfunctionDec 16, 2016Material Rupture; Physical Resistance

  IT WAS REPORTED THAT A 1.5X6MM MINI TREK DILATATION CATHETER ADVANCED TO THE MODERATELY TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING (LAD), HEAVILY CALCIFIED 99% STENOSED LESION WITH RESISTANCE DUE TO ANATOMY. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES AND RUPTURED. THE DEVICE WAS REPLACED WITH ANOTHER DILATATION DEVICE AND AN UNSPECIFIED STENT WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6183485 ↗