Mammotome HydroMARKRecalls & reported problems across all models

We found 2 models of Mammotome HydroMARK by Devicor Medical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, 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).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Mammotome HydroMARK recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 30, 2022Terminated

   Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.

   Z-1124-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported Mammotome HydroMARK problems

Mammotome HydroMARK models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mammotome HydroMARK CA000515003

  Marker, Radiographic, Implantable
  1 recall0 reports
• Mammotome HydroMARK CA000520002

  Marker, Radiographic, Implantable
  3 reports

Recent Mammotome HydroMARK adverse event reports

The 3 most recent reports across all models, 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 ↗

Other Devicor Medical Products, Inc. products

• Mammotome revolve12 models · 38 reports
• Mammotome EX2 models · 37 reports
• HydroMark11 models · 29 reports