MINI TREK 1012268-12URecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648176555), received between Sep 7, 2017 and Sep 30, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 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 7 most recent of 7 reports, 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 ↗
• MalfunctionDec 30, 2025Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A CALCIFIED, MILDLY TORTUOUS, LEFT CORONARY DIAGONAL ARTERY THAT IS 70% STENOSED WITH A PREVIOUSLY IMPLANTED VESSEL. DURING ADVANCEMENT OF THE 1.20X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) INSIDE A GUIDELINER RESISTANCE WAS MET WITH THE GUIDELINER AND THE SHAFT OF THE MINI TREK BDC KINKED AND BROKE INTO TWO PIECES INSIDE THE GUIDELINER. THE MINI TREK BDC NEVER MADE IT OUT OF THE GUIDELINER AND WAS REMOVED AS ONE UNIT. 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 23928059 ↗
• MalfunctionJan 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED AND 70% STENOSED. THE MINI TREK BALLOON RUPTURED IN THE PATIENT AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER MINI TREK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13184103 ↗
• MalfunctionJul 14, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE 1.20X12MM MINI TREK POUCH WAS CREASED AND THE DEVICE STERILITY WAS COMPROMISED. THERE WAS NO DAMAGE TO THE CHIPBOARD BOX. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10273131 ↗
• MalfunctionJun 29, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 1.2X12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE RCA AND THEN AFTER INFLATION IT WAS NOTED THAT THE BDC COULD NOT MOVE BACK ON THE GUIDE WIRE SO THE BDC WAS REMOVED. ANOTHER 2.0X15 MM MINI TREK BDC WAS USED IN THE RCA AND AFTER INFLATION IT WAS NOTED THE BDC COULD NOT MOVE BACK ON THE GUIDE WIRE SO ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ISSUES WITH INFLATION OR DEFLATION WITH EITHER BALLOON. 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 Consequences Or Impact To Patient

  MAUDE report 10207372 ↗
• MalfunctionJun 26, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO BEING GIVEN TO A HOSPITAL, THE DISTRIBUTOR NOTED THAT A 1.2X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) HAD A HOLE IN THE PACKAGING POUCH, WHICH LIKELY LED TO COMPROMISED STERILITY. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10201493 ↗
• MalfunctionSep 7, 2017Crack; Leak/Splash

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND PRIOR TO USE IN THE ANATOMY, THE TREK LEAKED AT THE HUB AREA DUE TO A CRACK IN THE LUER. THERE WAS NO PATIENT INVOLVEMENT; THE DEVICE WAS NOT USED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6850590 ↗