NC TREK 1012447-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648151781), received between Dec 29, 2021 and Dec 29, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Failure 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.

• InjuryDec 29, 2021Off-Label Use; Material Separation; Failure to Advance; Off-Label Use; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POSTERIOR TIBIAL ARTERY. A 2.5X25MM NC TREK BALLOON FAILED TO CROSS DUE TO ANATOMY WHEN IT WAS THEN NOTED THAT THE BALLOON BECAME DETACHED FROM THE SHAFT. THE DETACHED BALLOON WAS SUCCESSFULLY REMOVED WITH A SNARE. THE PROCEDURE CONTINUED WITH A NC BALLOON, AND THE TARGET LESION WAS TREATED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110664 ↗