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SenoMark® Breast Tissue Marker SMTSU9GRecalls & reported problems

Senorx, Inc. · SENOMARK® Breast Tissue Marker, 9 Ga ATEC, Titanium "O" · 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 00801741031991), received between Jan 7, 2019 and Jan 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING PLACEMENT OF A BREAST TISSUE MARKER, THE HEALTHCARE PROVIDER NOTED THAT THE MARKER TIP PROTECTOR ALLEGEDLY DETACHED INSIDE THE PATIENT. REPORTEDLY, IT WAS REMOVED BY VACUUM ASSISTED BIOPSY MACHINE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8223022 ↗

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