HydroMark CA000407005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841911100119), received between Apr 15, 2020 and Jan 28, 2026 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SALES REP THAT AFTER SUCCESSFUL DEPLOYMENT OF THE HYDROMARK ( 4010-02-15-T4) AN ARTIFACT WAS SEEN ON THE POST MAMOGRAM. THIS INCIDENT HAS BEEN RECORDED IN COMPLAINT #(B)(4). DEVICOR COULD NOT CONCLUDE THAT OUR DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT, DUE TO THE ALLEGATION OF AN ARTIFACT SEEN ON THE POST MAMOGRAM THIS HAS BEEN DETERMINED TO BE REPORTABLE PURSUANT TO 21 CFR 803. AS SUCH, WE ARE SUBMITTING THIS MEDWATCH REPORT.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 9965873 ↗