MINI TREK 1012268-08URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648176548), received between Jun 18, 2019 and Nov 9, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY THAT WAS A CHRONIC TOTAL OCCLUSION. THE 1.20X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, BUT DURING THE 1ST INFLATION AT RATED BURST PRESSURE, THE BALLOON RUPTURED, POSSIBLY DUE TO THE CALCIFICATION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER MINI TREK WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762976 ↗
• MalfunctionJul 7, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY TORTUOUS AND 95% STENOSED. DURING ADVANCEMENT OF THE MINI TREK, IT WAS NOTICED THAT BLOOD COMING WAS BACK ON THE SHAFT. WHEN THE DEVICE WAS REMOVED, THERE WAS A HOLE PROXIMAL TO THE RAPID EXCHANGE PORT (HOLE IN SHAFT). THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951334 ↗
• MalfunctionJun 18, 2019Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ON REMOVAL OF A 1.20 X 8 MM MINI TREK BALLOON DILATATION CATHETER (BDC) FROM THE DISPENSER COIL WITH NO REPORTED RESISTANCE, THE PROXIMAL SHAFT KINKED AND SEPARATED. THE BDC WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW UNSPECIFIED BDC WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8710186 ↗