Mammotome HydroMARK CA000520002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841911102434), received between Aug 10, 2023 and Jun 6, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER THE PROCEDURE. WHEN THE PROBE IS REMOVED, THE RADIOLOGIST REALIZED THAT THE CLIP HAD BEEN RELEASED, BUT A PIECE OF PLASTIC FROM THE DISTAL END OF THE PROBE HAS BROKEN OFF. THE PROCEDURE WAS COMPLETED WITH DEVICE. NO PATIENT CONSEQUENCES. COMPLAINT REPORTED TO AUTHORITY - ANSM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22158031 ↗
• MalfunctionMar 6, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THIS EVENT OCCURRED BEFORE BREAST BIOPSY PROCEDURE. IN THIS FACILITY, ONLY THE HYDROMARK WAS PULLED OUT FIRST AFTER MARKER PLACEMENT, NOT TOGETHER WITH THE PROBE. THE PROCEDURE AFTER HYDROMARK PLACEMENT HAS NOT YET BEEN CHANGED. AFTER MARKER PLACEMENT, ONLY THE HYDROMARK IS REMOVED. THEN CLOSE THE PROBE APERTURE AND PULL OUT THE PROBE THE PROCESS IS CARRIED OUT AS ABOVE. THEREFORE, THE HYDROGEL WAS CUT WHEN THE PROBE APERTURE WAS CLOSED. THE FACILITY EXPLAINED THAT NO FRAGMENT REMAINED INSIDE THE PATIENT BODY. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536271 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER THE PROCEDURE. THE BIOPSY WAS PREFORMED VIA MAMMOTOME REVOLVE ULTRASOUND. THE HYDROMARK CLIP WAS DEPLOYED THROUGH THE PROBE. THE BIOPSY AND DEPLOYMENT ALL WENT GOOD AND NOTHING APPEARED TO BE WRONG. WHEN PLACING A HYDROMARK CLIP MARKER IN A BIOPSY CASE, THE PATIENT WOULD NOT STOP BLEEDING AND HAD TO BE TAKEN TO SURGERY. PATIENT WENT INTO SURGERY AND THE MARKER WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17500832 ↗