Mammotome elite CA000137013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841911102793), received between Jan 2, 2025 and Feb 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THIS EVENT OCCURRED AFTER BREAST BIOPSY PROCEDURE. AFTER THE BIOPSY, THE PLASTIC PIECE WAS FOUND IN THE SAMPLE CUP. THIS PROBE AND FOREIGN OBJECTS WERE DISCARDED BY THE FACILITY. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432210 ↗
• MalfunctionJan 15, 2025Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER THIS EVENT OCCURRED AFTER BREAST BIOPSY PROCEDURE. AFTER THE BIOPSY, THE PLASTIC PIECE WAS FOUND IN THE SAMPLE CUP. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158314 ↗
• MalfunctionJan 15, 2025Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THIS EVENT OCCURRED AFTER BREAST BIOPSY PROCEDURE. AFTER THE BIOPSY, THE PLASTIC PIECE WAS FOUND IN THE SAMPLE CUP. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158214 ↗
• MalfunctionJan 10, 2025Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THIS EVENT OCCURRED AFTER BREAST BIOPSY PROCEDURE. AFTER COLLECTING THE SPECIMEN, THE TECHNOLOGIST FOUND A PIECE OF PLASTIC IN THE SAMPLE CUP. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124024 ↗
• MalfunctionJan 2, 2025Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THIS EVENT OCCURRED AFTER BREAST BIOPSY PROCEDURE. AFTER THE BIOPSY, THERE WAS A PIECE OF PLASTIC IN THE SAMPLE CUP. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056770 ↗