Mammotome revolve MammoMark MMK1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911100522), received between Jun 24, 2022 and Oct 15, 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS A TIP SHEAR OF MMK1003. THE RADIOLOGIST NOTICED THE TIP SHEAR BEFORE THE STEREOTACTIC BIOPSY WAS FINISHED AND WAS ABLE TO REMOVE THE TIP BEFORE COMPLETION OF THE PROCEDURE. RADIOLOGIST CONFIRMED THAT THE APERTURE WAS FULLY OPEN DURING MARKER DEPLOYMENT. PER THE ACCOUNT, "THE RADIOLOGIST NOTICED THE PLASTIC PIECE WHEN WE TOOK THE IMAGE WHEN HE WAS PLACING THE MARKER. HE CHANGED THE DIRECTION OF THE PROBE, AND WE TOOK ANOTHER IMAGE, AND THE PLASTIC WAS BACK IN THE MARKER DEVICE". THE PROBLEM OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED MMK1003. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300723 ↗
• InjuryJun 24, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE THAT THE TIPS OF THE MARKER (BLUE COLOUR PLASTIC) DETACHED AND REMAIN IN THE PATIENT BREAST. THE USER WANTS TO KNOW THE MATERIAL MADE OF THE PLASTIC TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 14806427 ↗