SecurMark MRI SMARK-M-SS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05420045503970), received between Jan 4, 2022 and Jun 25, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Migration” (9 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, THAT A SECURMARK MRI IMPLANTABLE BREAST MARKER WAS PLACED IN A PATIENT DURING AN MRI BIOPSY. IT IS REPORTED THAT DURING THE POST PLACEMENT MAMMOGRAM, A RING/CIRCLE WAS OBSERVED IN THE IMAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22328834 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158313 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158306 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158302 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158246 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158242 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158241 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158238 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158236 ↗
• MalfunctionJan 4, 2022Migration; Migration

  IT WAS REPORTED THAT DURING A EVIVA PROCEDURE, THE MARKER MIGRATED RESULTING IN THE PHYSICIAN HAVING TO USE ULTRASOUND TO PLACE A SECOND MARKER FOR SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158230 ↗