MINI TREK 1012268-15URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648176562), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DIAGONAL ARTERY. A 1.2 X 15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; HOWEVER, THE SHAFT SEPARATED WHEN INFLATING THE BALLOON TO 12 ATMOSPHERES. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED TREK BDC. 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 9105771 ↗