HydroMARK Breast Biopsy Site Marker CA000407010Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911102168), received between May 27, 2022 and May 27, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling 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.
Most reported problems
Device problems
- Device Markings/Labelling 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.
MalfunctionMay 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED BY THE AFFILIATE THAT DURING A PATIENT HAVING A BREAST CLIPS, WE USED A T4 LOT F12147319D, BUT COULD SEE THIS WAS NOT CORRECT AND LOOKED TO BE THE SAME AS THE T3 PLACED - LOT F12147317D. THE PATIENT WAS OK AND NO FURTHER CLIPS WERE PLACED. WE HAVE REMOVED ALL STOCK OF THIS T4 SO HAVE X19 TO RETURN AND BE REPLACED.
Patient problems: Foreign Body In Patient
MAUDE report 14526757 ↗
Other Marker, Radiographic, Implantable devices
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- 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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