Tumark® Vision for Eviva® Standard Tumark-E13-S-VisionRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250195611222), received between Dec 22, 2025 and May 1, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Patient Device Interaction Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT RECEIVED A TUMARK VISION FOR EVIVA STANDARD BREAST MARKER ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT THE PATIENT DEVELOPED A "SEVERE INFLAMMATORY REACTION," AND THE DEVICE WAS SURGICALLY REMOVED ON (B)(6) 2025. ADDITIONALLY, IT IS REPORTED THAT DIAGNOSIS OF THE EXCISED TISSUE CONFIRMED THE PRESENCE OF "FOREIGN BODY GRANULOMA."

  Patient problems: Inflammation

  MAUDE report 25057175 ↗
• InjuryDec 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN VACUUM ASSISTED EXCISION OF A B3 LESION ON (B)(6) 2025, THE LESION CONTAINED A TUMARK ¨VISION¨BREAST MARKER. THE VACUUM ASSISTED EXCISION WAS PERFORMED USING A 7G BD ENCORE DEVICE. THE FACILITY REPORTED THAT THE MARKER WAS DAMAGED DURING THE PROCEDURE AND SEVERAL SMALL FRAGMENTS WERE LODGED WITHIN THE SURROUNDING BREAST TISSUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23865831 ↗