Mammotome revolve CA000399016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911102724), received between Mar 3, 2023 and May 20, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K152989); they may or may not involve this specific model.

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 20, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT THE APPLICATOR TIP SHEARED OFF IN THE BREAST AFTER THE MARKER WAS DEPLOYED. THE MAMMOMARK WAS PLACED DURING AN UPRIGHT ST PROCEDURE USING THE REVOLVE 10G PROBE. THE MARKER APPLICATOR TIP WAS VISIBLE OUTSIDE THE BIOPSY CAVITY IN THE POST-PROCEDURE IMAGE. THE MARKER APPLICATOR HAS BEEN DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25229170 ↗
• MalfunctionMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AFFILIATE REPORTED THAT AFTER IMPLANTING A HYDROMARK, THERE WAS A FOREIGN OBJECT OF A PIECE OF METAL OTHER THAN THE COIL. ACCORDING TO THE FACILITY, IT DID NOT APPEAR TO BE PLUNGER SHEARING, BUT IT DID SHOW AN OBJECT OF A PIECE OF METAL THAT WAS CLEARLY A DIFFERENT SHAPE THAN THE OPEN COIL. IMMEDIATELY THE FACILITY REMOVED THE FOREIGN OBJECT FROM THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16482158 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152989. One submission often covers many models, so check the product and lot details in each record.

• Z-1512-2017 · Feb 28, 2017 · Terminated
  Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance