TriMark TRIMARKTD-2S-13-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420045503338), received between Sep 17, 2026 and Sep 17, 2026 — classified as 1 malfunction.

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

• MalfunctionSep 17, 2026Material Fragmentation

  It was reported by the user site that, "During biopsy, radiologist tried to deploy marker. Device shot off like a gun. It deployed the marker, but looks like the metal on inside exploded." Customer outreach confirmed that "metal was sticking out of the side of aperture/hole area" and that this was "only identified when removed from the breast." Despite the reported issue, the marker was successfully deployed and the procedure was completed using the same device. No patient or user harm was reported, and no additional medical or surgical intervention were required due to this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802636 ↗