Mammotome MAMMOMARK 2 P71796G07Recalls & reported problems
Devicor Medical Products, Inc. · MammoMARK Biopsy Site Identifier 8G U Shape- CE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911100447), received between Apr 11, 2019 and Apr 12, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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 Damaged by Another Device1
- Use of Device Problem1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2021Use of Device Problem; Use of Device Problem
IT WAS REPORTED BY THE AFFILIATE THAT DURING A CLIP PLACEMENT/ BIOPSY SITE MARKING PROCEDURE AT THE END OF THE PROCEDURE, THE RADIOLOGIST TRIED TO PLACE A BIOPSY MARKER. BUT THE MARKER GUIDE EXTREMITY BROKE INSIDE THE PATIENT'S BREAST LEAVING A 16MM DEBRIS IN THE BREAST. THIS EVENT IS DOCUMENTED IN OUR SYSTEM AS (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11654167 ↗InjuryApr 11, 2019Device Damaged by Another Device; Device Damaged by Another Device
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE, (B)(4), STATING, DURING THE PROCEDURE THE DROP BUTTON WAS HARD TO USE AND DEFECTIVE SO THE TIP OF THE MARKER APPLICATOR HAS BEEN STUCK IN THE APERTURE OF THE PROBE AND CUT DURING PULLING BACK TO REMOVE FROM THE PROBE. THE TIP OF THE MARKER APPLICATOR IS INSIDE THE PATIENT'S BREAST. THE PATIENT IS SCHEDULED TO HAVE SURGERY TO REMOVE THE CANCEROUS LESION REVEALED BY THE VACUUM ASSISTED BIOPSY PROCEDURE; THE APPLICATOR TIP WILL BE REMOVED AT THAT TIME. THE PATIENT HAS NOT COMPLAINED OF ANY SECONDARY EFFECTS. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 8504925 ↗
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.
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