SenoMark® Ultra Breast Tissue Marker SMEC7RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741032011), received between Sep 19, 2018 and Sep 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2018Positioning Failure; Difficult to Insert; Difficult to Remove; Positioning Failure; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT DURING PLACEMENT OF A BREAST TISSUE MARKER, THE MARKER APPLICATOR ALLEGEDLY WAS DIFFICULT TO INSERT INTO THE PROBE. THE CLIP WAS UNABLE TO DEPLOY AND THE MARKER APPLICATOR WAS REMOVED WITH DIFFICULTY AND THE TIP OF THE APPLICATOR ALLEGEDLY DETACHED AND REMAINED IN THE SAMPLE NOTCH OF THE PROBE. IT WAS FURTHER REPORTED THAT A SECOND CLIP WAS NOT PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7892033 ↗