SecurMark SMARK-EVIVA-2S-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05420045503628), received between Sep 25, 2021 and Mar 20, 2026 — classified as 2 injuries, 2 malfunctions.

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

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT REPORTED THAT A PATIENT RECEIVED A SECURMARK BREAST MARKER ON AN UNKNOWN DATE IN 2016. THE PATIENT REPORTS THAT "WORSENING PAIN" WAS EXPERIENCED; THEREFORE, THE MARKER WAS REMOVED ON AN UNKNOWN DATE IN 2017. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24650259 ↗
• InjuryDec 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A BREVERA PROCEDURE, A TUMARK PROFESSIONAL MARKER WAS DEPLOYED. PATIENT REPORTED THAT IT BLEED CONSIDERABLY AFTER THE PROCEDURE WAND THAT THE MARKER HAD MIGRATED 2.5 CM. LATER PATIENT REPORTED SHE KEPT BLEEDING AND THAT PAIN STARTED WITHIN DAYS AND THE INCISION BEGAN TO ITCH INTENSELY. PATIENT REPORTED THAT A MRI SCAN WAS SCHEDULED AND THAT THE CANCER WAS UNABLE TO BE FOUND AT THE TIME DUE TO MULTIPLE FACTORS SUCH AS DENSE BREASTS, LACK OF VISIBILITY AND THE MIGRATION OF THE MARKER. DUE TO THIS THE PROVIDER USED 2 ADDITIONAL MARKERS A SECURMARK FOR EVIVA, TOPHAT AND MINICORK TO MARK THE BIOPSY SITES. THE PATIENT REPORTED THAT THE SECOND MARKER IMPLANTATION WAS EXTREMELY PAINFULL AND THAT PATHOLOGY CAME BACK WHICH THE PROVIDED RECOMMENDED A DIGITAL MOTION X-RAY WITH IMPLANTS TO AVOID DISFIGUREMENT. DURING THAT PERIOD THE MARKERS SEEMED TO IRRITATE AND CHEST PAIN WAS REPORTED. A 2ND MEDICAL OPINION WAS REQUESTED WHICH RESULTED IN A LUMPECTOMY ON AN UNKNOWN DATE WITH A ELUCENT SMARTCLIP PLACED ON THE DAY PRIOR. DURING THE LUMPECTOMY THE MARKER FELL UPON INCISION DUE TO THE SUPERFICIAL POSITION IN THE SUPERIOR ANTERIOR MARGIN. PER THE RECORDS

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21014469 ↗
• MalfunctionSep 25, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT ON (B)(6) 2021 , DURING A BREAST BIOPSY PROCEDURE , THE SAMPLES WERE TAKEN AND THE SECUR MARK FOR EVIVA , DID NOT DEPLOY. IMAGES TAKEN AFTER THE PROCEDURE DID NOT SHOW A CLIP IN THE BREAST CAVITY. NO MARKERS WERE PLACED IN THE BREAST. PATIENT WAS DISCHARGED WITHOUT THE MARKERS AND WAS NOT SCHEDULED FOR ANOTHER SURGERY TO INSERT A NEW MARKER. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530919 ↗
• MalfunctionSep 25, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT ON (B)(6) 2021 , DURING A BREAST BIOPSY PROCEDURE , THE SAMPLES WERE TAKEN AND THE SECUR MARK FOR EVIVA , DID NOT DEPLOY. IMAGES TAKEN AFTER THE PROCEDURE DID NOT SHOW A CLIP IN THE BREAST CAVITY. NO MARKERS WERE PLACED IN THE BREAST. PATIENT WAS DISCHARGED WITHOUT THE MARKERS AND WAS NOT SCHEDULED FOR ANOTHER SURGERY TO INSERT A NEW MARKER. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530918 ↗