MINI TREK™ 1012269-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648138089), received between Aug 5, 2016 and Aug 5, 2024 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT CIRCUMFLEX ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 3.0X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE. THE DEVICE WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN PROTECTIVE SHEATH WAS REMOVED. THE 3.0X15 MM TREK BDC WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 7 ATMOSPHERES. A CUTTING BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913538 ↗
• MalfunctionSep 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT POSTERIOR ATRIO-VENTRICULAR (RPAV) CORONARY ARTERY WITH MILD CALCIFICATION AND TORTUOSITY AND 90% STENOSIS. THE 1.5X8 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO 6 ATMOSPHERES FOR 5 SECONDS AND RUPTURED. A NEW SAME SIZE MINI 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 17818949 ↗
• MalfunctionSep 8, 2023Difficult 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 99% STENOSED LESION IN THE OBTUSE MARGINAL (OM) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 1.5X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND RESISTANCE WAS NOTED DUE TO THE ANATOMY. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED AND RESISTANCE WAS ALSO NOTED DUE TO THE ANATOMY. A NEW TREK BDC WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED TO THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712854 ↗
• MalfunctionJul 10, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. POST-STENT IMPLANTATION OF A 2.5X15MM XIENCE STENT, THE 2.0X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS NOTED DUE THE ANATOMY AND THE BDC FAILED ADVANCE. THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY AND RESISTANCE WAS ALSO NOTED DUE TO THE ANATOMY. THEN, A 1.5X8MM MINI TREK BDC ALSO MET WITH RESISTANCE DUE TO THE ANATOMY AND WAS UNABLE TO CROSS THE TARGET LESION. THE SECOND BDC WAS REMOVED FROM THE ANATOMY AND RESISTANCE WAS NOTED DUE TO THE ANATOMY. A NON-ABBOTT BDC WAS USED IN THE PROCEDURE FOR POST-DILATATION. THERE WAS NO ADVERSE PATIENT EFFECT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291776 ↗
• MalfunctionDec 24, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 1.5X8MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE, HOWEVER, THERE WAS RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE BALLOON RUPTURED. THE BALLOON WAS INFLATED TWICE AT 11 ATMOSPHERES (ATMS) EACH TIME. THERE WAS NO RESISTANCE DURING REMOVAL. THERE WAS NO RESISTANCE WHEN PROTECTIVE SHEATH WAS REMOVED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045792 ↗
• MalfunctionMay 27, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND MODERATELY CALCIFIED CHRONIC TOTALLY OCCLUDED LESION IN THE RIGHT CORONARY ARTERY. A 1.5X8MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. ADDITIONALLY, THE BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED MINI TREK BDC. 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 11897415 ↗
• MalfunctionMar 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY THAT WAS 90% STENOSED. THE MINI TREK RX BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING THE FIRST INFLATION TO 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SAME SIZE MINI TREK RX WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11548202 ↗
• MalfunctionJun 22, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 1.50X8MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. DURING REMOVAL OF THE BDC RESISTANCE WITH THE ANATOMY WAS ALSO FELT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT DEVICE AND THE DEPLOYMENT OF AN UNSPECIFIED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179614 ↗
• MalfunctionJan 2, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED, CONCENTRIC, HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE 1.5X8 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND RUPTURED ON THE FIRST INFLATION TO 8 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE AND A NEW 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 Consequences Or Impact To Patient

  MAUDE report 9541873 ↗
• MalfunctionJun 11, 2019Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 1.5 X 8MM MINI TREK BALLOON CATHETER WAS PREPARED FOR USE PRIOR TO REMOVING THE PROTECTIVE SHEATH. WHEN REMOVING THE DEVICE FROM THE DISPENSER COIL, THE SOFT TIP SEPARATED FROM THE BALLOON. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8687444 ↗
• MalfunctionFeb 6, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. DURING UNPACKING, THE PROXIMAL SHAFT OF A 1.5 X 8 MM MINI TREK BALLOON CATHETER SEPARATED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8310210 ↗
• MalfunctionApr 13, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE OBTUSE MARGINAL USING BALLOON ANGIOPLASTY ONLY. THE 1.5 X 8 MM MINI TREK BALLOON CATHETER WAS BEING ADVANCED OVER THE PROXIMAL END OF THE GUIDE WIRE WHEN THE PROXIMAL SHAFT OF THE BALLOON CATHETER SEPARATED IN TWO PIECES. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER ON THE GUIDE WIRE. ANOTHER SAME SIZE MINI TREK BALLOON WAS ABLE TO BE USED WITHOUT ISSUE, FOLLOWED BY MULTIPLE OTHER BALLOONS TO COMPLETE THE CASE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6488946 ↗
• MalfunctionFeb 20, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE FIRST MARGINAL CORONARY ARTERY. A 1.50X08MM MINI TREK BALLOON DILATATION CATHETER RUPTURED AFTER IT WAS INFLATED TO 8 ATMOSPHERES ONE TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 1.5 AND 2.0 NON-ABBOTT BALLOON DILATATION CATHETERS. 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 6344471 ↗
• MalfunctionAug 5, 2016Material Rupture

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE TO TREAT A CONCENTRIC, HEAVILY CALCIFIED, 90% STENOSED, 3.0MM DIAMETER X 20MM-LONG LESION IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, A 1.5X8MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND PREPPED VIA AIR ASPIRATION OUTSIDE OF THE ANATOMY. NO RESISTANCE WAS FELT WHEN REMOVING THE PROTECTIVE BALLOON SHEATH. THE 1.5X8MM MINI TREK RX BDC WAS THEN ADVANCED ACROSS THE TARGET LESION WITHOUT RESISTANCE TO PERFORM PRE-DILATATION. THE MINI TREK BDC WAS INFLATED ONCE TO 8 ATMOSPHERES (ATM) WITHOUT ISSUE. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 10 ATM AFTER 15 SECONDS. THE RX MINI TREK BDC WAS WITHDRAWN WITHOUT RESISTANCE. AN UNSPECIFIED 2.0MM BALLOON CATHETER WAS USED TO COMPLETE PRE-DILATATION, FOLLOWED BY IMPLANTATION OF AN UNSPECIFIED STENT, SUCCESSFULLY COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5851923 ↗