TrailBlazer™ Angled ASC-018-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000004842), received between Dec 4, 2019 and Dec 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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 4, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING AN ANGLED TRAILBLAZER DEVICE AS PART OF A PROCEDURE. IT WAS REPORTED THE CATHETER BROKE IN THE SHEATH WHEN TRYING TO ADVANCE, PRIOR TO INSERTION INTO THE PATIENT. A NEW TRAILBLAZER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, IT WAS NOTED THE DEVICE WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9409470 ↗