TriMark TRIMARK TD 13MRRecalls & reported problems
Hologic, Inc. · TriMark TrapDoor (TD) · Class 2 · Implant
All models of TriMark (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05420045503291), received between Jul 6, 2021 and May 8, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, AN ARTIFACT RESEMBLING METAL WAS OBSERVED IN THE PATIENT´S BREAST AFTER A MRI BIOPSY IN ADDITION TO THE MARKER (TRIMARK MARKER) THAT WAS DEPLOYED AT THE TIME. THE RADIOLOGIST RECOMMENDED THE PATIENT TO HAVE THE SURGERY TO HAVE THE MATERIAL REMOVED AND THE BIOPSY WAS BENIGN. NO ISSUES WERE REPORTED DURING SET UP AND PATIENT RECEIVED ANOTHER MAMMOGRAM ON (B)(6) 2025 DUE TO ARTIFACT. SURGERY IS SCHEDULED FOR (B)(6) 2025. NO OTHER INFORMATION AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 21989622 ↗MalfunctionJul 6, 2021Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT, DURING A BIOPSY PROCEDURE, WHEN PLACING THE BIOPSY MARKER THE RADIOLOGIST DEPLOYED THE MARKER AS USUAL. WHEN THE MARKER DEVICE WAS REMOVED FROM THE BREAST IT WAS NOTED THE MARKER WAS STUCK IN THE APERTURE. REDEPLOYMENT WAS NOT ATTEMPTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12122419 ↗
Other MARKER, RADIOGRAPHIC, IMPLANTABLE devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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