Mammotome revolve MammoMark MMK0801Recalls & reported problems
Devicor Medical Products, Inc. · Biopsy Site Identifier- Non 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 00841911101376), received between Dec 14, 2022 and Dec 9, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
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
- Use of Device Problem2
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.
InjuryDec 9, 2025Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THERE WAS A TIP SHEAR INCIDENT. ACCOUNT WAS USING A MAMMOTOME 8G PROBE WITH AN AFFIRM SYSTEM. THE RADIOLOGIST FINISHED TAKING SAMPLES AND DIALED BACK 10MM IN PREPARATION TO PLACE THE MARKER. THE RADIOLOGIST HAD A HARD TIME DEPLOYING THE MARKER, NOTICING THAT THERE WAS RESISTANCE. THEY ALSO NOTICED THAT IT WAS DIFFICULT TO PULL THE PROBE AND MARKER OUT OF THE BREAST. THE TECH REPORTS THAT THE PROBE AND THE INTRODUCER WERE REMOVED FROM THE BREAST TOGETHER. MARKER TIP WAS DISCOVERED INSIDE OF THE BREAST UPON POST-BIOPSY MAMMOGRAM. UPDATE: UPON CALLING THE ACCOUNT FOR ADDITIONAL INFORMATION, IT WAS MADE KNOWN THAT THE PATHOLOGY FROM THE BIOPSY CAME BACK POSITIVE AND THE PATIENT WILL BE GOING TO SURGERY TO REMOVE THE TISSUE. THE PROBLEM OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED MARKER. NO PATIENT COMPLICATIONS WERE NOTED.
Patient problems: Foreign Body In Patient
MAUDE report 23759254 ↗InjuryDec 14, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING PROCEDURE THAT THERE WAS A TIP SHEAR DURING MARKER DEPLOYMENT. WE HAVE NOT RECEIVED CONFIRMATION AS TO WHETHER OR NOT THE TIP SHEAR HAS BEEN OR WILL BE REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 15982767 ↗
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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