HydroMark 4010-02-15-T4Recalls & reported problems
Devicor Medical Products, Inc. · HydroMARK Breast Biopsy Site Marker- MICRO · Class 2 · Implant
All models of HydroMark (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911101482), received between Aug 15, 2019 and Aug 15, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM THE USER FACILITY STATING, A BUTTERFLY SHAPED TITANIUM HYDROMARK MARKER WAS PLACED IN (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN SINCE THAT TIME AND REQUESTED REMOVAL OF THE MARKER. THE CLIP WAS REMOVED (B)(6) 2019. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).
Patient problems: Patient Problem/Medical Problem
MAUDE report 8897042 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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