MammoStar™ STAR1102Recalls & reported problems

Carbon Medical Technologies, Inc. · Biopsy Site Identifier · Class 2 · Implant

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 00858015005400), received between May 27, 2024 and May 27, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

Reports received per month

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

Most reported problems

Device problems

Patient-Device Incompatibility1
Prophylactic removal due to corrective action1

Patient problems

Foreign Body Reaction1

Recent adverse event reports

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

InjuryMay 27, 2024Patient-Device Incompatibility; Prophylactic removal due to corrective action; Patient-Device Incompatibility; Prophylactic removal due to corrective action
A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT AN FOREIGN BODY REACTION WAS OBSERVED WITH A CAUSAL ASSOCIATION. CLINICAL MANAGEMENT INCLUDED ORAL MEDICATION RESULTING IN A FULL RECOVERY. DESPITE A WARNING IN THE IFU, THE MARKER WAS INSERTED INTO A BLOOD VESSEL.
Patient problems: Foreign Body Reaction
MAUDE report 19399249 ↗

Device details

UDI-DI	`00858015005400`
Brand	MammoStar™
Model	STAR1102
Company	Carbon Medical Technologies, 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 Safe
Status	In Commercial Distribution
Record updated	Sep 18, 2023

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.