Mammotome revolve MHUS10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911100829), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Obtain Sample” (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 16, 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.

• MalfunctionSep 6, 2018Failure to Obtain Sample; Failure to Obtain Sample

  REPORT RECEIVED FROM AFFILIATE, DEVICOR MEDICAL (B)(4) STATING, "ONCE PROBE WAS INSERTED IN THE PATIENT, SAMPLE CUP DID NOT ROTATE, AND SAMPLING BUTTON WAS NOT FUNCTIONING. NEW PROBE WAS ATTACHED TO HOLSTER, IT FUNCTIONED PROPERLY TO COMPLETE THE PROCEDURE." THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850155 ↗

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