MINI TREK 1012268-20URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648176579), received between Dec 6, 2019 and Dec 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionDec 6, 2019Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 1.20X20MM RX MINI TREK BALLOON DILATATION CATHETER MET RESISTANCE WITH AN UNSPECIFIED 7F GUIDING CATHETER DURING ADVANCEMENT. THE BALLOON REACHED THE TARGET LESION AND DURING WITHDRAWAL, RESISTANCE WAS MET AGAIN WITH THE GUIDING CATHETER AND THE SHAFT SEPARATED. THE DISTAL PORTION WAS RETRIEVED WITH THE GUIDING CATHETER AS A SINGLE UNIT. PER THE PHYSICIAN, THE SHAFT SEPARATED DUE TO THE ANGLE OF THE VESSEL. A NEW BALLOON 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 9429918 ↗