SecurMark MRI SMARK-M-SS3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420045503994), received between Jun 1, 2026 and Jun 1, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJun 1, 2026Migration

  IT WAS REPORTED THAT A SECURMARK STOPLIGHT MRI CLIP WAS PLACED IN A PATIENT'S BREAST ON (B)(6) 2026, AND THE CORRECT LOCATION/PLACEMENT WAS CONFIRMED UNDER MAMMO. IT IS FURTHER REPORTED THAT AFTER THE PROCEDURE, WHILE THE PATIENT WAS AT HOME, THE ENCASEMENT SURROUNDING THE CLIP CAME OUT OF THE PATIENT'S BREAST. THE USER SITE REPORTS THAT THE ENCASEMENT WAS REMOVED BY THE PHYSICIAN AND REIMAGING WAS DONE, WHICH CONFIRMED THAT THE CLIP ITSELF REMAINED IN THE CORRECT POSITION. NO PATIENT HARM WAS REPORTED; HOWEVER, INJURY MDR IS BEING SUBMITTED DUE TO THE ADDITIONAL INTERVENTIONS THAT WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348887 ↗