HydroMARK Breast Biopsy Site Marker CA000413004Recalls & reported problems

Devicor Medical Products, Inc. · HydroMARK Breast Biopsy Site Marker- CE · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911102199), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Use of Device Problem1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJul 15, 2025Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER THE PROCEDURE. THERE WAS DIFFICULT PLACEMENT OF THE HYDROMARK. THE HYDROMARK REMAINS IN THE BARD NEEDLE. THE SPRING GETS STUCK BEHIND THE NEEDLE OPENING. THIS MAKES IT DIFFICULT TO REMOVE THE SYSTEM. A PIECE OF THE SPRING REMAINED IN THE CHEST. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 22508292 ↗

Device details

UDI-DI	`00841911102199`
Brand	HydroMARK Breast Biopsy Site Marker
Model	CA000413004
Catalog no.	4010-03-09-T3
Company	Devicor Medical Products, Inc.
Product code	NEU · Marker, Radiographic, Implantable
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 19, 2026

Device type (GMDN): Radiological image marker, implantable

A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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