HydroMARK Breast Biopsy Site Marker CA000407009Recalls & 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 00841911102151), received between Mar 25, 2021 and Mar 25, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use 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.
InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POTENTIAL ALLERGIC REACTION AFTER THE BIOPSY BREAST MARKER (HYDROMARK) WAS INSERTED IN THE MORNING AND SUBSEQUENTLY DEVELOPED DIFFUSE UTICARIAL TYPE RASH OVER THE BODY AND SHORTNESS OF BREATH IN THE EVENING. PATIENT ATTENDED ED DEPARTMENT FOR INVESTIGATION - SYMPTOMS RESOLVED, TREATMENT FOR REACTION (UTICARIA) WAS NOT SPECIFIED AND TREATMENT FOR REACTION (SHORTNESS OF BREATH) WAS NOT SPECIFIED. THIS INCIDENT HAS BEEN RECORDED IN COMPLAINT #(B)(4).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11572811 ↗
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