HydroMark CA000413002Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841911100140), received between Feb 17, 2022 and Oct 15, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

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

  ACCORDING TO THE REPORTER, THIS EVENT OCCURRED AFTER BREAST BIOPSY PROCEDURE. AFTER MARKER PLUG PLACEMENT, THE PLUNGER BECAME CAUGHT IN THE PROBE APERTURE, CAUSING SIGNIFICANT RESISTANCE. UPON REMOVAL OF THE PROBE AND HYDROMARK, THE HYDROMARK PLUNGER WAS FOUND TO BE EXTENDED. ADDITIONALLY, THE MARKER COULD NOT BE PLACED AND WAS STUCK TO THE PLUNGER. CONFIRMATION WITH THE FACILITY INDICATED THE DAMAGED PLUNGER WAS NOT FRACTURED, AND NO FRAGMENTS REMAINED INSIDE THE BODY. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290016 ↗
• InjuryJul 22, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THIS EVENT HAPPENED AFTER CLIP PLACEMENT/BIOPSY SITE MARKING. PRIOR TO THE CASE, A RECOMMENDATION WAS GIVEN TO DR. (B)(6) FOR VACUUMING THE CAVITY BEFORE DEPLOYING THE MARKER AND NOT TO CLOSE THE PROBE APERTURE AFTER MARKER DEPLOYMENT TO PREVENT PLUNGER SHEAR. DURING THE PROCEDURE, IT WAS RECOMMENDED TO DR. (B)(6) TO DO A STANDARD VACUUM WITH ENCOR VAB SYSTEM. THE DOCTOR DECLINED AND PROCEEDED WITH MARKER DEPLOYMENT. TURN THE PROBE APERTURE 180 DEGREE FROM THE MARKER PLACEMENT. DR. (B)(6) ALSO PREFERRED TO CLOSE THE PROBE APERTURE DESPITE BEING ADVISED AND EXPLANATION WAS GIVEN. WHILE THE DOCTOR CLOSED THE APERTURE OF THE PROBE, THERE WAS A CRACKING SOUND HEARD. THE DOCTOR REMOVED THE PROBE AND MARKER AS ONE FROM THE PATIENT'S BODY. POST MARKER IMAGE WAS COMPLETED ONLY AFTER THE PROBE AND MARKER WAS REMOVED FROM PATIENT'S BODY. POST MARKER IMAGE SHOWED OPEN COIL MARKER WAS DEPLOYED SUCCESSFULLY BUT A CIRCLE SHAPE OF PLUNGER ROD SEEN NEXT TO THE MARKER. PATIENT WAS INFORMED REGARDING THE PLUNGER ROD AND AWAITING FOR THE SPECIMEN RESULT TO DECIDE THE NEXT OF ACTION. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22565926 ↗
• InjuryMay 29, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS A PLUNGER SHEAR WITH (1) 4010-03-09-T3. THE INCIDENT OCCURRED DURING AN ULTRASOUND BIOPSY USING MAMMOTOME REVOLVE. MARKER WAS DEPLOYED, ROTATED 180 DEGREES, AND REMOVED BOTH PROBE AND APPLICATOR AT THE SAME TIME. HOWEVER, UPON REACHING THE SKIN SURFACE, PART OF THE SPRING WAS NOTICED. THE DOCTOR HAD TO CUT PART OF THE SPRING WITH THE DISTAL END OF THE CUTTER FOR IT TO RELEASE. THE RADIOLOGIST INFORMED THE PATIENT OF THE 3-4 MM RETAINED FOREIGN BODY. THE PATIENT IS AWARE THAT IF THE BIOPSY IS BENIGN, THEN SHE WILL NEED SURGERY TO GET THE SPRING REMOVED. NO OTHER COMPLICATIONS. NO PATIENT SYMPTOMS. THE PROBE AND APPLICATOR HAVE BEEN DISCARDED. CURRENTLY AWAITING IMAGES. THE PROCEDURE WAS COMPLETED. NO PATIENT SYMPTOMS. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22108349 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS A PLUNGER SHEAR WITH (1) 4010-03-09-T3. THE INCIDENT OCCURRED DURING A STEREOTACTIC BIOPSY USING THE HOLOGIC AFFIRM AND MAMMOTOME REVOLVE. THE RADIOLOGIST INFORMED THE PATIENT OF THE 2 MM RETAINED FOREIGN BODY. NO OTHER COMPLICATIONS. NO PATIENT SYMPTOMS. THE SPRING (FOREIGN BODY) REMAINS IN THE BREAST. THE PROBLEM OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22018609 ↗
• InjuryJul 18, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THIS EVENT HAPPENED AFTER CLIP PLACEMENT/BIOPSY SITE MARKING. THE SPRING OF THE MARKER WAS CAUGHT IN THE APERTURE AND DAMAGED. SPRING EXTENDED BUT PROBABLY NOT BROKEN. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773547 ↗
• InjuryFeb 10, 2023Use of Device Problem; Use of Device Problem

  THE REPRESENTATIVE REPORTED THAT AFTER THEY INSERTED THE MARKER THEY MANUALLY TURN THE PROBE AND THERE WAS A SMALL AMOUNT OF RESISTANCE. THEY TOOK AN X-RAY AND THERE WAS NO VISIBLE MARKER. THE TECHNICIAN MOVED THE PROBE BACK INTO THE BIOPSY POSITION AND TRIED TO DEPLOY THE MARKER AGAIN. THIS TIME THE MARKER STUCK TO THE PLUNGER. WHEN THEY TRIED TO DEPLOY THE DEVICE TO INSERT A NEW ONE THE TECHNICIAN FELT RESISTANCE. THEY TOOK A NEW IMAGE AND THE PLUNGER COIL WAS VISIBLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16353547 ↗
• InjuryNov 28, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE THAT DURING PROCEDURE, A 39 YEAR OLD PATIENT UNDERWENT A NEEDLE BIOPSY OF THE LEAFT BREAST. IN ADDITION TO THE T3 CLIP, THE TIP OF THE CLIP INTRODUCER IS ALSO IN THE BIOPSY BED. IMAGES WERE REVIED WITH THE PATIENT AT THE TIME OF BIOPSY. IMAGES WERE REVIEWED WITH THE PATIENT AT THE TIME OF THE BIOPSY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15868956 ↗
• InjuryApr 11, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED BY SALES REPRESENTATIVE THAT DURING THE PROCEDURE AFTER THE MARKER WAS DEPLOYED THE PATIENT PASSED OUT. THE PROBE WAS QUICKLY RETRACTED OUT BUT A SPRING WAS CAUGHT IN THE BREAST. WHILE REMOVING THE SPRING THE TECHNICIAN RAMMED HER KNUCKLE INTO THE PROBE. THE TECHNICIAN HAD TO GO TO THE EMERGENCY ROOM FOR BBF PROTOCOL.

  Patient problems: Abrasion

  MAUDE report 14079740 ↗
• InjuryFeb 17, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY SALES REPRESENTATIVE THE CUSTOMER HAD A TIP SHEAR IN WHICH SOME OF THE METAL SPRING WAS LEFT IN THE BREAST. THERE WERE NO PATIENT COMPLAINTS. ACCORDING TO THE SALE REPRESENTATIVE THERE IS NO PLAN FOR ADDITIONAL SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13553290 ↗