Mammotome revolve MSTH1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841911100706), received between Apr 2, 2020 and Dec 27, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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.

• InjuryDec 27, 2023Unintended System Motion; Unintended System Motion

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED BEFORE BREAST BIOPSY PROCEDURE. BEFORE THE PIERCING, A 505 ERROR OCCURRED AND THE HOLSTER DISARMED. THE PROBE NEEDLE ADVANCED SLOWLY, AND NEEDLE WAS INSERTED INTO THE PATIENT'S BREAST. THE CUSTOMER REQUESTED AN INVESTIGATION INTO THIS EVENT. PROCEDURE WAS COMPLETED WITH DEVICE. THE CUSTOMER REPORTED NO PATIENT COMPLICATIONS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18397861 ↗
• MalfunctionApr 2, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT BEFORE PROCEDURE, IE DURING SET UP, THIER MSTH1 HOLSTER FIRED THE NEEDLE IMMEDIATELY AFTER ARMING THE HOLSTER. NO PATIENT COMPLICATIONS WERE REPORTED. THIS INCIDENT HAS BEEN RECORDED IN COMPLAINT #(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919074 ↗

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