HydroMarkRecalls & reported problems across all models

We found 11 models of HydroMark by Devicor Medical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2017 and Aug 7, 2026 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (11 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. 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

Most reported HydroMark problems

HydroMark models

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

• HydroMark CA000413002

  Marker, Radiographic, Implantable
  9 reports
• HydroMark CA000407004

  Marker, Radiographic, Implantable
  7 reports
• HydroMark CA000407005

  Marker, Radiographic, Implantable
  3 reports
• HydroMark CA000408002

  Marker, Radiographic, Implantable
  2 reports
• HydroMark 4010-01-11-T3

  Marker, Radiographic, Implantable
  2 reports
• HydroMark CA000407003

  Marker, Radiographic, Implantable
  1 report
• HydroMark CA000413001

  Marker, Radiographic, Implantable
  1 report
• HydroMark 4010-02-15-T1

  Marker, Radiographic, Implantable
  1 report
• HydroMark 4010-02-15-T4

  Marker, Radiographic, Implantable
  1 report
• HydroMark 4010-03-09-T3

  Marker, Radiographic, Implantable
  1 report
• Hydromark CA000520005

  Marker, Radiographic, Implantable
  1 report

Recent HydroMark adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Use of Device Problem

  According to the reporter,  there were deployment issues with the HydroMark during a prone procedure using the Revolve 10g probe. The first marker did not deploy and confirmed that it was not stuck inside the applicator. Marker 1 Deployment Steps Confirmed by the Customer: 1. The aperture was rotated to 6:00, and the arrow was also pointing at 6:00. 2. The tech was not in the room, but she suspects that the marker applicator was not advanced until a definitive stop was felt. 3. The aperture was fully opened. 4. The plunger was pressed until a click was heard. 5. The probe and marker applicator were rotated 180 degrees away from deployment, and both were removed together.After this, another marker was inserted, which potentially led to a plunger shear. Following the procedure, a plastic fragment was discovered at the patient's biopsy site and was subsequently removed. Marker 2 Deployment Steps Confirmed by the Customer: 1. The aperture was rotated to 6:00, and the arrow was also pointing at 6:00. 2. The marker applicator was advanced until a definitive stop was felt. 3. The aperture was fully opened. 4. The plunger was pressed until a click was heard. 5. The probe and marker applica

  Patient problems: Foreign Body In Patient

  MAUDE report 50174848 ↗
• MalfunctionJun 5, 2026Inaccurate Information

  TECH REPORTED ONE BOX OF MISLABELED HYDROMARK. TWO CLIPS WERE DEPLOYED IN PATIENT; ACCT WOULD NOT PROVIDE POST-IMAGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDROMARK. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: Breast Mass

  MAUDE report 25418131 ↗
• InjuryFeb 23, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE NURSE/CLINICAL QUALITY SAFETY SPECIALIST, A PATIENT HAD A REACTION TO A HYDROMARK MARKER. THE BIOPSY TOOK PLACE IN EARLY (B)(6) 2025. THE BIOPSY WAS ULTRASOUND GUIDED AND USED A 14G SPRING LOADED BIOPSY DEVICE. TWO CORE SAMPLES WERE OBTAINED AND THE MARKER WAS PLACED. THE MARKER APPLICATOR WAS DISCARDED AND THE LOT NUMBER WAS NOT DOCUMENTED. THE NEXT DAY THE PATIENT COMPLAINED OF REDNESS, BRUISING AND PAIN AT THE BIOPSY SITE. SIX DAYS POST BIOPSY, THE PATIENT DEVELOPED A RASH AND STEROID CREAM WAS HELPFUL IN ALLEVIATING THE SYMPTOM. ON (B)(6) 2025 THE PATIENT RECEIVED A DIAGNOSTIC WORKUP OF MAMMOGRAM AND ULTRASOUND. THE PATIENT WAS COMPLAINING OF ITCHING AND SKIN CHANGES WERE NOTED. THE RADIOLOGIST RECOMMENDED A SURGICAL CONSULTATION FOR REMOVAL OF THE MARKER. ON (B)(6) 2025 THE MARKER WAS SURGICALLY REMOVED. THE PATIENT WAS SEEN (B)(6) 2026 AND IT WAS NOTED THAT SHE WAS STILL HEALING FROM THE SURGERY. THE PATIENT HAS KNOWN ALLERGIES OF SULFA DRUGS AND PENICILLIN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24416694 ↗
• InjuryJan 28, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED AN ACUTE ALLERGIC REACTION IMMEDIATELY FOLLOWING HYDROMARK IMPLANTATION, PRESENTING WITH TONGUE AND THROAT EDEMA AND LOCALIZED REDNESS AT THE SITE. EMERGENCY RESPONSE WAS INITIATED, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE PATIENT WAS GIVEN EPINEPHRINE IN THE BREAST CENTER AND AGAIN LATER THAT EVENING IN THE ER. SYMPTOMS RESOLVED WITHIN HOURS BUT RECURRED APPROXIMATELY 12 HOURS LATER AND ON TWO SUBSEQUENT OCCASIONS. THE PATIENT WAS PRESCRIBED CORTICOSTEROIDS TO MANAGE THE SYMPTOMS. NO MARKER REMOVAL IS PLANNED AS THE LESION IS BENIGN. ADDITIONAL INFORMATION: PATIENT HAS ALPHA-GAL SYNDROME (AGS) AND INQUIRED WHETHER POLYETHYLENE GLYCOL (PEG) CONTAINS MAMMALIAN-DERIVED COMPONENTS. THE MARKER WAS IMPLANTED BY DIRECT PUNCTURE. THE MARKER APPLICATOR WAS DISCARDED AFTER USE. THE PROBLEM OCCURRED AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED MARKER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24200150 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER THE PROCEDURE AND THE PATIENT HAD AN ALLERGIC REACTION TO A HYDROMARK OPEN-COIL TITANIUM MARKER. THE REPORTER DID NOT HAVE THE PRODUCT CODE OR THE LOT NUMBER OF THE MARKER USED. ON (B)(6) 2025, ABOUT 3 HOURS POST MARKER PLACEMENT, THE PATIENT DEVELOPED HIVES AND FELT HOT. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS TREATED WITH EPINEPHRINE. THE MARKER WAS SURGICALLY REMOVED TWO DAYS LATER ON (B)(6) 2025. THE PATIENT'S SYMPTOMS ARE RESOLVING. THE PATIENT IS ALLERGIC TO LATEX, ALTHOUGH NO LATEX WAS USED DURING THE BIOPSY. THE BIOPSY DEVICE BEING USED WAS A HOLOGIC BREVERA 9G NEEDLE. THIS WAS A STEREOTACTIC GUIDED BIOPSY. COMPLAINT DEVICE: -4010-04-09-T3 -LOT #F12526208D OR LOT# F12509102D-ACCOUNT DOES NOT KNOW WHICH LOT WAS USED. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23310763 ↗
• 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 ↗
• InjuryMar 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THERE WAS AN ALLERGIC REACTION TO (1) 4010-02-15-T3. THE PATIENT EXPERIENCED AN ALLERGIC REACTION 6 HOURS AFTER AN ULTRASOUND-GUIDED BIOPSY USING THE EVIVA BIOPSY MACHINE. SHE ARRIVED AT THE EMERGENCY ROOM VIA EMERGENCY MEDICAL SERVICES WITH THE FOLLOWING SYMPTOMS: SYNCOPE, HIVES, HYPOTENSION 60S/40S, ALTERED MENTAL STATUS CHANGES, PALE IN COLOR, DIAPHORETIC WEAKNESS. THE PATIENT WAS TREATED WITH AN EPINEPHRINE INTRAVENOUS (IV) DRIP AND REMOVED AFTER SIX HOURS. THE MARKER WAS SURGICALLY REMOVED FIVE DAYS LATER. THE ISSUE OCCURRED AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE PRIOR TO ISSUE. THE PATIENT EXPERIENCED A COMPLICATION, EXPLAINED AS AN ALLERGIC REACTION. SURGICAL REMOVAL OF MARKER WAS PERFORMED TO SOLVE THE PATIENT COMPLICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21645020 ↗
• InjuryMar 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THERE WAS AN ALLERGIC REACTION TO THE MARKER 4010-02-15-T4. THE DOCTOR HAD A PATIENT EXPERIENCE AN ALLERGIC REACTION 24 HOURS AFTER AN ULTRASOUND-GUIDED BIOPSY USING AN ALCOHOL SWAB, LIDOCAINE 1%, AND ADHESIVE DRESSING. THE PATIENT EXPERIENCED HIVES ALL OVER HER BODY WHICH LASTED FOR ABOUT 72 HOURS AND RESOLVED WITH PREDNISONE AND ZYRTEC. THE MARKER REMAINS IN THE PATIENT'S BREAST. THE PROBLEM OCCURRED AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED MARKER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21643361 ↗
• 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 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER THE PROCEDURE. A PATIENT HAD AN ULTRASOUND BIOPSY AND THE HYDROMARK WAS DEPLOYED. THERE WERE OBVIOUS POSITIVE FINDINGS/CANCER. PATIENT WAS FINE POST PROCEDURE, RETURNED HOME, DEVELOPED A RASH AND HIVES A FEW HOURS LATER. PATIENT WENT TO THE EMERGENCY ROOM AND WAS ADMINISTERED BENADRYL AND EPINEPHRINE. PATIENT WAS DISCHARGED AND WENT BACK TO THE EMERGENCY ROOM WITH THE RASH AGAIN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18079078 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE HYDROGEL (POLYETHYLENE GLYCOL) THAT SURROUNDS THE HYDROMARK TISSUE MARKER. THE HYDROMARK WAS PLACED DURING A STEREO BIOPSY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16941480 ↗
• 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 ↗

Other Devicor Medical Products, Inc. products

• Mammotome HydroMARK2 models · 3 reports · 1 recall
• Mammotome revolve12 models · 38 reports
• Mammotome EX2 models · 37 reports