Skip to content

SenoMark® Breast Tissue Marker SMSE9GTRecalls & reported problems

Senorx, Inc. · SENOMARK® Breast Tissue Marker, 9 Ga Eviva, Titanium "X" · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741031960), received between May 20, 2022 and May 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Patient-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 20, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT POST BREAST MARKER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGY. HOWEVER NO ADDITIONAL INTERVENTION OR MEDICATION PERFORMED TO TREAT THIS ALLERGY. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14449630 ↗

Other MARKER, RADIOGRAPHIC, IMPLANTABLE devices

All MARKER, RADIOGRAPHIC, IMPLANTABLE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page