HydroMark CA000407004Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841911100102), received between Feb 24, 2020 and Jun 5, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPRESENTATIVE REPORTED A 38-YEAR-OLD PATIENT HAD AN ALLERGIC REACTION AFTER THE HYDROMARK T3 MARKER WAS DEPLOYED. THE PATIENT RECEIVED HYDROMARK T3 LOT AND IS IN ICU FROM HAVING AN ANAPHYLACTIC REACTION. THE PATIENTS ONLY KNOWN ALLERGY IS PENICILLIN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16158362 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MONDAY MORNING 13 SEPTEMBER "I HAD A BREAST BIOPSY PERFORMED WHERE THE RADIOLOGIST INSERTED ONE OF YOUR PRODUCTS - A BREAST BIOPSY SITE MARKER (HYDROMARK). ON MONDAY AFTERNOON I LANDED UP IN THE EMERGENCY ROOM WITH AN ANAPHYLACTIC ALLERGIC REACTION. THE ALLERGIST THAT I HAVE BEEN REFERRED TO IS TRYING TO RULE OUT VARIOUS POSSIBILITIES, SO AS THIS WAS THE ONLY UNFAMILIAR EVENT OF THE DAY FOR ME I WOULD LIKE TO KNOW WHAT ARE THE COMPONENTS OF THE HYDROMARK. IN OTHER WORDS, PLEASE WOULD YOU INFORM ME AS TO THE METALS THAT ARE IN THIS PRODUCT AS I NEED TO BE TESTED TO SEE IF ANY OF THE SUBSTANCES ARE RESPONSIBLE FOR THIS SERIOUS ALLERGIC REACTION. PLEASE WOULD YOU TREAT THIS AS AN URGENT REQUEST. THANKS FOR PROMPT ASSISTANCE WITH THIS (B)(6) NO PRODUCT INFORMATION PROVIDED." ALLERGIC REACTION HAS NOT BEEN CONFIRMED TO BE CAUSED BY OUR DEVICE. THIS EVENT HAS BEEN REPORTED AS COMPLAINT NUMBER (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12643678 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SALES REPRESENTATIVE AFTER PROCEDURE, ST MODALITY, A PATIENT - HAD A REACTION POST BIOPSY. PATIENT COMPLICATION DETAILS: REDNESS AND PAIN TO THE BREAST - SENT TO THE ER. THE CUSTOMER DID NOT PROVIDE THE NECESSARY INFORMATION TO DETERMINE THE SEVERITY OF HARM OF THE ALLEGED INJURY. DEVICOR IS REPORTING ON THE ALLEGATION OF INJURY ONLY. IF ANY NEW ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE INJURY WILL BE CHARACTERIZED ACCORDINGLY. THIS INCIDENT HAS BEEN RECORDED IN COMPLAINT #(B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Patient Problem/Medical Problem; Reaction

  MAUDE report 9748405 ↗