MammoStar™ STAR1401Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00858015005424), received between Mar 23, 2020 and May 27, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT AN INFECTION WAS OBSERVED WITH A PROBABLE ASSOCIATION. CLINICAL MANAGEMENT INCLUDED TOPICAL MEDICATION, PATIENT OUTCOME IS UNKNOWN. THE PROCEDURE WAS CARRIED OUT DESPITE THE PRESENCE OF AN INFECTION, WHICH IS A KNOWN RISK FACTOR.

  Patient problems: Unspecified Infection

  MAUDE report 19399290 ↗
• InjuryMay 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT AN IMMUNE RESPONSE WAS OBSERVED WITH A CAUSAL ASSOCIATION. CLINICAL MANAGEMENT INCLUDED TOPICAL MEDICATION RESULTING IN A FULL RECOVERY. THE PROCEDURE WAS CARRIED OUT DESPITE THE PRESENCE OF AN INFECTION, WHICH IS A KNOWN RISK FACTOR. DESPITE A WARNING IN THE IFU, THE MARKER WAS INSERTED INTO A BLOOD VESSEL.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19399287 ↗
• InjuryMay 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT HYPERSENSITIVITY WAS OBSERVED WITH A PROBABLY ASSOCIATION TO THE DEVICE OR PROCEDURE. CLINICAL MANAGEMENT WAS NOT REPORTED RESULTING IN A PARTIAL RECOVERY. IT WAS ALSO NOTED THAT THE PROCEDURE WAS CARRIED OUT DESPITE THE PRESENCE OF AN INFECTION, WHICH IS A KNOWN RISK FACTOR.

  Patient problems: Local Reaction

  MAUDE report 19387896 ↗
• MalfunctionMar 23, 2020Failure to Advance

  DEVICE FAILED TO DEPLOY AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864743 ↗