SenoMark® Breast Tissue Marker SMEC10GSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741031915), received between Feb 21, 2018 and May 19, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 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 14446612 ↗
• InjuryJun 4, 2021Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE PATIENT HAD EXCESSIVE BLEEDING DUE TO MULTIPLE TIME REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11937162 ↗
• MalfunctionApr 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL SMEC10GSS MARKER ALLEGEDLY EXPERIENCED PATIENT-DEVICE INCOMPATIBILITY. THIS REPORT WAS RECEIVED FROM ONE SOURCES. THE DEVICE WAS USED IN THE PATIENT, A (B)(6) YEAR-OLD FEMALE, OF (B)(6) LBS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525439 ↗
• MalfunctionJun 7, 2018Positioning Failure; Difficult to Remove; Failure to Advance; Positioning Failure; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DURING A MAMMOGRAPHIC-GUIDED BREAST BIOPSY FOR A SMALL CLUSTER OF CALCIFICATIONS, THE MARKER ALLEGEDLY FAILED TO ADVANCE, FAILED TO DEPLOY, AND AFTERWARDS FAILED TO BE REMOVED FROM THE PROBE. REPORTEDLY, THE PATIENT WAS GIVEN MORE LOCAL ANESTHESIA (LIDOCAINE) AND THE PROBE AND A PORTION OF THE MARKER WERE REMOVED AS ONE UNIT FROM THE PATIENT, WHILE THE CUTTER WAS OPEN. POST PROCEDURE IMAGING INDICATED THAT A PORTION OF THE MARKER WAS ALLEGEDLY SHEARED OFF BY THE CUTTER AND NOW REMAINS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580884 ↗
• MalfunctionFeb 21, 2018Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE MARKER APPLICATOR TIP WAS NOTED TO HAVE DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287759 ↗