TriMark TRIMARKTD-2S-36-09Recalls & reported problems
Hologic, Inc. · TriMark TrapDoor (TD) · Class 2 · Implant
All models of TriMark (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05420045503352), received between Apr 19, 2019 and Apr 24, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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 18, 2026.
Most reported problems
Device problems
- Component Missing1
- Failure to Eject1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2019Failure to Eject; Failure to Eject
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, "THE CLIP DID NOT COME OUT DURING THE PROCEDURE." NO INJURY OR MISDIAGNOSIS REPORTED. A SECOND DEVICE WAS USED AND A SITE MARKER WAS SUCCESSFULLY PLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8545478 ↗MalfunctionApr 19, 2019Component Missing; Component Missing
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE THE "CLIP DID NOT COME OUT DURING THE PROCEDURE." NO INJURY OR MISDIAGNOSIS REPORTED. A SECOND DEVICE WAS USED AND A SITE MARKER WAS SUCCESSFULLY PLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8532054 ↗
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.
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