Hydromark CA000520005Recalls & reported problems
Devicor Medical Products, Inc. · HydroMark Breast Biopsy Site Marker -Non CE · 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 00841911103677), received between Aug 7, 2026 and Aug 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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
- Use of Device Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Use of Device Problem
According to the reporter, there were deployment issues with the HydroMark during a prone procedure using the Revolve 10g probe. The first marker did not deploy and confirmed that it was not stuck inside the applicator. Marker 1 Deployment Steps Confirmed by the Customer: 1. The aperture was rotated to 6:00, and the arrow was also pointing at 6:00. 2. The tech was not in the room, but she suspects that the marker applicator was not advanced until a definitive stop was felt. 3. The aperture was fully opened. 4. The plunger was pressed until a click was heard. 5. The probe and marker applicator were rotated 180 degrees away from deployment, and both were removed together.After this, another marker was inserted, which potentially led to a plunger shear. Following the procedure, a plastic fragment was discovered at the patient's biopsy site and was subsequently removed. Marker 2 Deployment Steps Confirmed by the Customer: 1. The aperture was rotated to 6:00, and the arrow was also pointing at 6:00. 2. The marker applicator was advanced until a definitive stop was felt. 3. The aperture was fully opened. 4. The plunger was pressed until a click was heard. 5. The probe and marker applica
Patient problems: Foreign Body In Patient
MAUDE report 50174848 ↗
Other Marker, Radiographic, Implantable devices
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- 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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