SenoMark® Ultra Breast Tissue Marker SMEV9RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741032134), received between Sep 16, 2024 and Feb 10, 2026 — classified as 2 malfunctions.

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.

• MalfunctionFeb 10, 2026Component Missing; Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE BY USING THE SENO MARK ULTRA. IT WAS REPORTED THAT PRIOR THE PROCEDURE, THE STERILE DEVICE WAS ALLEGEDLY OPENED AND FOUND TO BE MISSING ITS PROTECTIVE CAP. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302050 ↗
• MalfunctionSep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT EXPERIENCED WEIRD SENSATION, RASHES IN THE CHEST AREA AND ABDOMEN WITH ASSOCIATED NAUSEA. IT WAS FURTHER REPORTED THAT THE PATIENT HAS HAD THE MARKER IN PLACE FOR ONE AND HALF A YEAR. HOWEVER, THE PATIENT DID NOT UNDERWENT ANY MEDICAL INTERVENTION NOR MEDICATIONS PRESCRIBED FOR RASHES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225742 ↗