SecurMark SMARK-EVIVA-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05420045503611), received between Apr 18, 2019 and Mar 10, 2026 — classified as 6 injuries, 3 malfunctions.

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

• MalfunctionMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE USER SITE THAT WHILE ATTEMPTING TO COMPLETE A PROCEDURE WITH A SECURMARK BIOPSY SITE MARKER ON (B)(6), THE MARKER WAS DEPLOYED; HOWEVER, "WE BELIEVE THE MARKER WAS STUCK TO THE END OF THE INTRODUCER." THE USER FURTHER REPORTS THAT A SECOND MARKER DEPLOYMENT WAS ATTEMPTED WITH A SECOND DEVICE FROM THE SAME LOT AND "THE MARKER DEPLOYED BUT THERE WAS NO MARKER PRESENT WHEN THE MD PULLED THE INTRODUCER OUT AND TRIED TO CONFIRM THE MARKER DEPLOYMENT. THERE WAS A PIECE OF PLASTIC THAT DEPLOYED, BUT NO MARKER PRESENT." ADDITIONAL INFORMATION WAS OBTAINED FROM THE USER, AND IT IS REPORTED THAT THE "PLASTIC" WAS OBSERVED UPON REMOVING THE INTRODUCER FROM THE PATIENT AND "THE PLASTIC DID NOT STAY IN THE PATIENT." NO PATIENT INJURY WAS REPORTED, AND THE MARKER DEPLOYMENT WAS COMPLETED WITH ANOTHER DEVICE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562775 ↗
• InjurySep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN EVIVA SECURMARK PROCEDURE ON (B)(6) 2025, THE BIOPSY MARKER FRACTURED AND APPEARED TO BE TWO PIECES IN THE POST PROCEDURE IMAGE. THE USER REPORTS THAT THE MARKER WAS DEPLOYED IN THE INTENDED LOCATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964075 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED 2 MARKERS ON (B)(6) 2015 THROUGH MRI GUIDED NEEDLE BIOPSY. ONE IN EACH BREAST. PATIENT REPORTED THAT SHE EXPERIENCED SHOOTING PAINS AND ELECTRICAL SHOCK ON HER RIGHT BREAST AND A POSSIBLE MIGRATION ON HER LEFT BREAST. PATIENT REPORTED SHE IS ALLERGIC TO TITANIUM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 21333089 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED 2 MARKERS ON (B)(6) 2015 THROUGH MRI GUIDED NEEDLE BIOPSY. ONE IN EACH BREAST. PATIENT REPORTED THAT SHE EXPERIENCED SHOOTING PAINS AND ELECTRICAL SHOCK ON HER RIGHT BREAST AND A POSSIBLE MIGRATION ON HER LEFT BREAST. PATIENT REPORTED SHE IS ALLERGIC TO TITANIUM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 21333088 ↗
• 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 BLED 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 I

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21014470 ↗
• InjuryJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SMARK FOR EVIVA PROCEDURE ON (B)(6) 2024, DURING THE CLIP PLACEMENT A METALLIC FOREIGN BODY WAS LEFT BEHIND IN THE BREAST. AN IMAGE OF THE BREAST WAS PROVIDED A RADIOPAQUE OBJECT COULD BE OBSERVED. NO PATIENT INJURY REPORTED, AND NO ADDITIONAL MEDICAL INTERVENTIONS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19594765 ↗
• MalfunctionAug 18, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT A PATIENT UNDERWENT BIOPSY PROCEDURE ON (B)(6) 2022. THE BIOPSY WAS SUCCESSFULLY COMPLETED, AND THE MARKER (S-MARK EVIVA WAS DEPLOYED VIA AN INTRODUCER IN THE BREAST. HOWEVER, WHEN IMAGES WERE CHECKED, NO MARKER WAS VISIBLE. INTRODUCER AND SITE MARKER WERE THEN REMOVED FROM THE BREAST. IT WAS FOUND THAT THE SITE MARKER HAD VISIBLY PERFORATED THE INTRODUCER. AS DECIDED BY THE RADIOLOGIST, NO SECOND MARKER WAS NOT DEPLOYED, BECAUSE THE INTRODUCER WAS REMOVED FROM THE SITE. AS REPORTED, THERE WAS NO PATIENT INJURY/HARM, BUT THE PATIENT WAS LEFT WITHOUT THE BIOPSY MARKER IN THE BREAST. THE PATIENT WILL NOT RETURN FOR ANOTHER MARKER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255786 ↗
• MalfunctionAug 26, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING THE PROCEDURE THE MARKER FAILED TO DEPLOY THREE TIMES. ALL MARKERS THAT FAILED WERE FROM THE SAME LOT. THE PROCEDURE LENGTH WAS EXTENDED AND THEREFORE THE PATIENT REMAINED UNDER COMPRESSION FOR LONGER THAN NECESSARY. BIOPSY WAS COMPLETED WITH NO MARKER PLACED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8933002 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO TECHNOLOGISTS WERE SETTING UP A TRAY FOR A STEREOTACTIC BIOPSY, THE LAST THING THEY OPENED WAS THE PACKAGE TO THE SECURMARK MARKER AND SECONDS AFTER THEY NOTED BURING AND WHITE MARKS ON THEIR FINGERS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER LATER THAT SAME DAY NOTED THE WHITE COLORING WAS FADING, BUT SOME SWELLING AND TINGLING SENSATION REMAINED. THE TECHNOLOGISTS HAD APPLIED ICE TO THE AFFECTED AREA AND USED RUBBING ALCOHOL AND HYDROGEN PEROXIDE ON THE WHITE MARKINGS. THEY WERE EVALUATED BY EMPLOYEE HEALTH, BUT NO MEDICAL INTERVENTION WAS GIVEN. IT WAS NOTED THAT THE TECHNOLOGISTS WERE NOT WEARING GLOVES WHILE HANDLING THE PACKAGING. A SECOND CUSTOMER FOLLOW-UP WAS MADE ON (B)(6) 2019 AND IT WAS REPORTED THAT THE WHITE MARKS HAD DISAPPEARED AND THE SWELLING WENT DOWN.

  Patient problems: Burning Sensation; Skin Irritation; Swelling

  MAUDE report 8527799 ↗