TriMark TRIMARK-EVIVA-2S-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05420045503581), received between Oct 26, 2017 and Apr 13, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 18, 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.

• InjuryApr 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT RECEIVED A TRIMARK MARKER AND AFTER THE PROCEDURE DEVELOPED A SKIN RASH. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Rash

  MAUDE report 16733328 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THAT USED A TRIMARK FOR EVIVA , AFTER IMPLANTATION OF THE CLIP A CIRCULAR HYPERDENSITY WAS OBSERVED BEHIND THE CLIP, NO INJURY TO THE PATIENT WAS REPORTED, PATIENT DID NOT REQUIRED ADDITIONAL MEDICATION, IMAGING OR SURGERY, THE RESULTS OF THE BIOPSY WERE REPORTED AS BENING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14364411 ↗
• MalfunctionJun 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PHYSICIAN PERFORMED AN EVIVA NEEDLE BREAST BIOPSY ON (B)(6) 2018, AND THE SINGLE RELEASE SYSTEM DEPLOYED TWO MARKERS CAUSING A POTENTIAL RISK FOR MISDIAGNOSIS. THERE WAS NO PATIENT INJURY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7608601 ↗
• InjuryOct 26, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THE PHYSICIAN PERFORMED AN EVIVA NEEDLE BREAST BIOPSY ON (B)(6) 2017, AND THE SINGLE RELEASE SYSTEM DEPLOYED TWO MARKERS CAUSING A POTENTIAL RISK FOR MISDIAGNOSIS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6980827 ↗