HydroMARK Breast Biopsy Site Marker CA000413003Recalls & reported problems
Devicor Medical Products, Inc. · HydroMARK Breast Biopsy Site Marker- CE · Class 2 · Implant
Data updated Oct 18, 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 00841911102182), received between Dec 6, 2024 and Dec 6, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO THE REPORTER, THE PATIENT REQUIRED A BIOPSY AS A RESULT OF A ROUTINE PRE-OPERATIVE SCREENING MAMMOGRAM BEFORE BREAST REDUCTION PROCEDURE. THE EVENT HAPPENED AFTER CLIP PLACEMENT/BIOPSY SITE MARKING. THE EVENT OCCURRED USING STEREOTACTIC (ST) DEPLOYMENT, USING HOLOGIC ATEC VACUUM ASSISTED BIOPSY (VAB). THE MARKER DEPLOYED ON (B)(6) 2024 SUCCESSFULLY HOWEVER, AFTER A COUPLES OF DAYS, REDNESS, PAIN AND SWELLING WAS OBSERVED BY THE PATIENT. PRIOR TO DEPLOYMENT, IRON WAS DISCLOSED AS AN ALLERGY. THE PROCEDURE WAS COMPLETED. DURING THE PATIENT'S BREAST REDUCTION PROCEDURE ON (B)(6) 2024, HOOK WIRE WAS PLACED TO ENSURE THE MARKER CLIP WAS REMOVED. MARKER REMOVAL WAS NOT THE GOAL OF THE SURGERY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20864127 ↗
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- 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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