Mammotome revolve CA000399007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911102564), received between Feb 3, 2021 and Feb 3, 2021 — classified as 1 malfunction.

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

• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED BY SALES REP DURING PROCEDURE, FRAGMENTS LEFT IN BREAST AFTER FIRING AND BIOPSY. THIS INCIDENT HAS BEEN DOCUMENTED AS COMPLAINT # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11276874 ↗

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