SenoMark UltraCor™ MRI Breast Tissue Marker SMUCMRI14GSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741032141), received between May 18, 2021 and Nov 3, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE USING THE SENO MARKER. ONE WEEK LATER POST PLACEMENT, THE PATIENT REPORTED ITCHING ALL OVER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23448445 ↗
• MalfunctionMay 18, 2021Component Missing; Device Markings/Labelling Problem; Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PLASTIC SPACER WAS ALLEGEDLY MISSING AND THE LENGTH OF THE PRODUCT WAS NOT ACCURATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840378 ↗