TREK 1012405-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648153952), received between Apr 28, 2021 and Jun 30, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionJun 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING INFLATION OF THE 2.5X6 MM TREK BALLOON DILATATION CATHETER, THE BALLOON RUPTURED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS 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 22364462 ↗
• MalfunctionApr 28, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, THAT THE PROCEDURE WAS PERFORMED. TO TREAT A LESION IN THE LEFT ATRIAL OBLIQUE VEIN. A 2.5X6MM TREK BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE. AND THE BALLOON RUPTURED, DURING THE FIRST INFLATION AT 3 ATMOSPHERES. AN UNSPECIFIED TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE DEVICE WAS NOT IMMERGED IN SALINE, DURING PREP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738551 ↗