MINI TREK 1012268-06URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648176531), received between Mar 12, 2020 and Jan 19, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING REMOVAL OF THE 1.2X6MM MINI TREK BALLOON DILATATION CATHETER (BDC) FROM THE DISPENSER HOOP, THE SHAFT WAS NOTED TO HAVE BROKEN INTO 2 SEPARATE PIECES. ANOTHER SAME SIZE MINI TREK BALLOON 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 18548160 ↗
• InjuryMar 12, 2020Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN (LM) ARTERY. THE 1.20X6MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND THE BALLOON INFLATED THREE TIMES TO 20, 15, AND 15 ATMOSPHERES (ATM) RESPECTIVELY WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED HOWEVER IT WAS NOTED THE SHAFT HAD SEPARATED, THE DISTAL 10CM OF THE DEVICE REMAINED IN THE ANATOMY. ATTEMPTS TO RETRIEVE THE SEPARATED PORTION WERE UNSUCCESSFUL AND THE DEVICE REMAINS IN THE ANATOMY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) TO BE FURTHER MONITORED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9823562 ↗