SenoMark® UltraCor® Breast Tissue Marker SMUC10HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741032394), received between Oct 4, 2017 and Oct 21, 2023 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2023Migration; Migration

  IT WAS REPORTED THAT SOMETIME POST A BREAST TISSUE MARKER PLACEMENT, PATIENT ALLEGEDLY HAD A FLUID COLLECTIONS WITH AN INFECTION WHICH REQUIRED AN INCISION AND DRAINAGE. IT WAS FURTHER REPORTED THAT THE PATHOLOGY REVEALED MARKED ACUTE INFLAMMATION AND GRANULATION TISSUE CONSISTENT WITH ABSCESS. REPORTEDLY, THE LONG TERM INFECTION AND INFLAMMATION CAUSING THE PATIENT TO WALL OFF THE CLIP AND MIGRATING TO THE SKIN AND REJECTING IT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 17981901 ↗
• MalfunctionDec 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH NORMAL DENSITY TISSUE, AN MAMMOGRAM EXAMINATION DEMONSTRATED THAT THE DEPLOYED MARKER ALLEGED BROKEN INTO TWO PIECES IN PATIENT BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13092312 ↗
• MalfunctionDec 19, 2021Break; Nonstandard Device; Detachment of Device or Device Component; Break; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED MARKER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT BROKEN SEGMENTS STILL IN PATIENT. PATIENT CURRENT STATUS UNKNOWN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13041109 ↗
• InjuryOct 4, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGEDLY MAY HAVE A HEMATOMA AND IS EXPERIENCING ITCHING, SWELLING, AND WARMTH AT THE INJECTION SITE. THE PHYSICIAN WAS ADVISED AND STARTED THE PATIENT ON ANTIBIOTICS.

  Patient problems: Reaction, Injection Site

  MAUDE report 6913887 ↗