SenoMark® Breast Tissue Marker SMTEC10GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741031977), received between Feb 27, 2018 and May 7, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Break; Positioning Failure

  ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE SENOMARK. DURING THE PROCEDURE, THE TIP OF THE SENOMARK BROKE OFF AND GOT STUCK IN THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111655 ↗
• MalfunctionSep 22, 2025Device Emits Odor; Device Emits Odor

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106996 ↗
• MalfunctionSep 8, 2025Difficult to Remove; Difficult to Remove

  IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT A STEREOTACTIC GUIDANCE BIOPSY ALONG WITH THE PLACEMENT OF A BREAST TISSUE MARKER UTILIZING THE ENCORE AND SENOMARK MARKERS. DURING THE PROCEDURE, THE DEVICE'S NEEDLE BECAME STUCK IN THE PATIENT. ADDITIONALLY, IT WAS REPORTED WHETHER THE ISSUE WAS DUE TO A DEFECTIVE MARKER OR IF THE ENCORE DID NOT COMPLETELY ROTATE TO DETACH DURING THE BIOPSY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22989975 ↗
• MalfunctionAug 4, 2022Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY DIFFICULT TO INSERT TO BREAST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15162088 ↗
• MalfunctionJul 16, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL SMTEC10G BREAST TISSUE MARKER ALLEGEDLY EXPERIENCED A TEAR IN THE PACKAGE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10282895 ↗
• MalfunctionFeb 27, 2018Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING BREAST MARKER PLACEMENT UNDER STEREOTACTIC GUIDANCE, THE MARKER ALLEGEDLY REMAINED IN THE MARKER APPLICATOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300773 ↗