SenoMark® Ultra Breast Tissue Marker SMAT9CRecalls & reported problems
Bard Peripheral Vascular, Inc. · SENOMARK® ULTRA Breast Tissue Marker, 9 Ga ATEC, BioDur Coil · Class 2 · Implant
All models of SenoMark Ultra Breast Tissue Marker (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741032080), received between Sep 14, 2021 and Sep 16, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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
Device problems
- Device Contamination with Chemical or Other Material3
- Image Display Error/Artifact1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2021Image Display Error/Artifact; Device Contamination with Chemical or Other Material; Image Display Error/Artifact; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT POST BREAST MARKER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12479013 ↗MalfunctionSep 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BREAST MARKER PLACEMENT PROCEDURE, THE FOREIGN MATERIAL WAS ALLEGEDLY FOUND TO BE DEPLOYED UPON MARKER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12465989 ↗MalfunctionSep 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BREAST MARKER PLACEMENT PROCEDURE, THE FOREIGN MATERIAL WAS ALLEGEDLY FOUND TO BE DEPLOYED UPON MARKER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12465876 ↗
Other MARKER, RADIOGRAPHIC, IMPLANTABLE devices
- BioZorb F0202Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls192 reports
- BioZorb F0221Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
- BioZorb F0203Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls51 reports
- BioZorb F0231Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0303Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0304Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0404Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls6 reports
- BioZorb F0331Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page