Mammotome revolve MammoMark MMK0803Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911100492), received between Dec 20, 2019 and Mar 14, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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.

• InjuryMar 14, 2023Use of Device Problem; Use of Device Problem

  THE SALES REPRESENTATIVE REPORTED THAT DURING PROCEDURE THE SHEATH CAME OUT WITH CLIP INTO BREAST TISSUE. THE PROCEDURE WAS COMPLETED BUT THE PATIENT IS HAVING EXCISIONAL SURGERY TO REMOVE RADIAL SCAR ALONG WITH THE SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 16539449 ↗
• MalfunctionDec 20, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY A SALES REP THAT THE MARKER PLUG BROKE AS IT CAME OUT OF THE PATIENT. DR (B)(6) MANUALLY REMOVED THE REMAINDER OF THE PLUG FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS. THIS INCIDENT IS RECORDED AS COMPLAINT NUMBER (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9500999 ↗