MammoStar™ STAR0831Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858015005325), received between Nov 22, 2016 and Nov 19, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Expulsion” (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.

• InjuryNov 19, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS AFTER DEPLOYMENT OF THE MAMMOSTAR MARKER, THE PATIENT REPORTED THAT THE INCISION SITE HAD BEEN REOPENED AND THE MARKER CAME OUT.

  Patient problems: Foreign Body Reaction

  MAUDE report 10871794 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER DEPLOYMENT THE MARKER MOVED SUPERFICIAL UNDER THE SKIN. THIS, IN THE CUSTOMER OPINION, CAUSED AN INFECTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 7685479 ↗
• InjuryNov 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED THAT THE PATIENT DEVELOPED AN ALLERGIC REACTION (HIVES) SEVERAL WEEKS AFTER A BIOPSY SITE IDENTIFIER PLACEMENT PROCEDURE.

  Patient problems: Wheal(s)

  MAUDE report 6121826 ↗