MINI TREK™ 1012269-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648138119), received between Oct 25, 2016 and Jul 23, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). THE 1.5X20MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITHOUT ISSUES AND ADVANCED TO THE LESION. RESISTANCE WAS NOTED WITH THE ANATOMY. DURING THE INITIAL INFLATION, THE BALLOON RUPTURED AT 6ATMS. THE BDC WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580381 ↗
• InjuryJun 6, 2024Off-Label Use; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Off-Label Use; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 1.5X20 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TOWARDS THE LESION WHEN RESISTANCE WAS FELT WITH THE ANATOMY. THE DEVICE WAS PUSHED FORWARD BUT DID NOT CROSS AND THE TIP SEPARATED IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. A SNARE WAS USED TO REMOVE THE TIP WITHOUT ISSUE AND A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478006 ↗
• MalfunctionApr 3, 2023Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE 1.5X20MM MINI TREK BALLOON DILATATION CATHETER (BDC), THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE. ONCE REMOVED, THE BDC WAS ADVANCED TO THE LESION IN THE RIGHT CORONARY ARTERY (RCA) THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 80% STENOSED, BUT THE BALLOON DID NOT INFLATE AT ALL. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER MINI TREK WAS USED TO CONTINUE THE PROCEDURE, THEN A XIENCE XPEDITION WAS IMPLANTED, WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16666120 ↗
• MalfunctionJan 31, 2023Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Packaging Problem; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION OF THE 1.50X20MM MINI TREK A KINKED WAS NOTED AT A 70 ANGLE ON THE DEVICE. WHEN ATTEMPT WAS MADE TO STRAIGHTEN OUT THE KINKED, IT SNAPPED IN TWO PIECES BEFORE WAS FULLY REMOVED FROM THE HOOP. THE KINK ON THE HOOP WAS NOTED THAT ALIGNED WITH THE LOCATION OF THE KINK ON THE DEVICE. ANOTHER MINI TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR 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 16274072 ↗
• MalfunctionNov 4, 2019Inflation Problem; Off-Label Use; Deformation Due to Compressive Stress; Material Split, Cut or Torn; Inflation Problem; Off-Label Use; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MILDLY CALCIFIED AND MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY THAT WAS 100% STENOSED. A 1.5 X 20 MM MINI TREK BALLOON CATHETER WAS USED; HOWEVER, THE DISTAL SHAFT WHERE THE INNER/OUTER MEMBER ARE BECAME KINKED WHICH CAUSED A HOLE IN THAT AREA. THEREFORE, THE DEVICE WAS UNABLE TO INFLATE AS CONTRAST WAS LEAKING FROM THE HOLE. A 2.0 X 40 MM ARMADA 14 BALLOON CATHETER WAS THEN 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 Consequences Or Impact To Patient

  MAUDE report 9274887 ↗
• MalfunctionApr 29, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED, THROMBOTIC LESION AT THE OSTIUM OF THE RIGHT CORONARY ARTERY. A 1.50 X 20 MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INSERTED THROUGH AN UNSPECIFIED VALVE WITH NO RESISTANCE WHEN THE SHAFT OF THE BDC WAS ACCIDENTLY LOOPED AND A MID SHAFT SEPARATION OCCURRED. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. 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 8561125 ↗
• MalfunctionApr 22, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK WAS NOTED IN THE 1.5 X 20 MM MINI TREK BALLOON DILATATION CATHETER (BDC). THIS WAS DISCOVERED AS AIR WAS OBSERVED TO BE ENTERING THE INDEFLATOR DURING PREPARATION OF THE BDC. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW, SAME SIZE MINI TREK BDC WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8537991 ↗
• MalfunctionNov 7, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED ECCENTRIC LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 1.5 X 20 MM MINI TREK BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN STENT. 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 7007880 ↗
• MalfunctionApr 5, 2017Material Rupture

  IT WAS REPORTED THAT THE 1.5 X 20 MM MINI TREK BALLOON CATHETER BALLOON WAS TESTED PRIOR TO PLACING IN THE PATIENT ANATOMY. THE BALLOON RUPTURED AT 2 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6461912 ↗
• MalfunctionOct 25, 2016Material Rupture; Improper or Incorrect Procedure or Method; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE 1.50 X 20 MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) THROUGH THE LESION FOR PRE-DILATATION; HOWEVER, IT WAS ABLE TO CROSS SUCCESSFULLY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES HELD FOR 15 SECONDS. UPON REMOVAL OF THE RUPTURED MINI TREK FROM THE PATIENT'S ANATOMY, A PINHOLE ON THE BALLOON WAS OBSERVED. IT WAS STATED THAT AIR ASPIRATION OF THE DEVICE WAS PERFORMED INSIDE THE PATIENT'S ANATOMY. A REPLACEMENT NC TREK BDC WAS USED TO PERFORM THE PRE-DILATATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A XIENCE ALPINE STENT WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6054848 ↗