HydroMark CA000408002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911100195), received between May 16, 2023 and Oct 16, 2025 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗