SenoMark® Ultra Breast Tissue Marker SMMA11RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741032073), received between Feb 15, 2018 and Jul 15, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. 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.

• MalfunctionJul 15, 2020Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL SMMA11R BIOPSY INSTRUMENT STENT ALLEGEDLY FAILED TO DEPLOY AND DETACHMENT OF DEVICE COMPONENT. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. A FEMALE PATIENT'S AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10280378 ↗
• MalfunctionOct 16, 2019Positioning Failure; Difficult to Insert; Difficult to Remove; Positioning Failure; Difficult to Insert; Difficult to Remove

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL SMMA11R BREAST TISSUE MARKER ALLEGEDLY EXPERIENCED FAILURE TO INSERT / REMOVE, FAILURE TO DEPLOY, AND DEVICE DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS MALE AND THE AGE AND WEIGHT WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200135 ↗
• MalfunctionOct 9, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF A BREAST TISSUE MARKER, THE MARKER APPLICATOR ALLEGEDLY WAS DIFFICULT TO REMOVE FROM THE PROBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949058 ↗
• MalfunctionFeb 15, 2018Positioning Failure; Difficult to Remove; Detachment of Device or Device Component; Positioning Failure; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT, THE PLUNGER OF THE DEVICE ALLEGEDLY FAILED TO ADVANCE. THE APPLICATOR WAS ALSO ALLEGEDLY DIFFICULT TO REMOVE FROM THE PROBE. UPON REMOVAL FROM THE PROBE, THE APPLICATOR WAS FOUND DAMAGED. THE PROCEDURE WAS CONCLUDED WITH THE BREAST TISSUE UNMARKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7274940 ↗