Mammotome revolve MST1012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911100751), received between Sep 29, 2020 and Sep 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• InjurySep 29, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED VIA MEDWATCH VOLUNTARY EVENT REPORT THAT DURING A STEREOTACTIC LEFT BREAST BIOPSY PROCEDURE, A 12 CM, 10 GAUGE MAMMOTOME REVOLVE NEEDLE WAS INADVERTENTLY LOADED IN MAMMOTOME INSTEAD OF A 9 CM, 10 GAUGE NEEDLE. BIOPSY OF LEFT BREAST LESION WAS PERFORMED. POST BIOPSY IMAGES SHOWED A 4 MM V SHAPED RETAINED METALLIC FRAGMENT IN LEFT BREAST. INSPECTION OF THE NEEDLE SHOWED A DAMAGED CANNULA AT THE TIP. PATIENT WAS IMMEDIATELY REFERRED TO BREAST CLINIC AND SEEN BY BREAST SURGEON. PATIENT SCHEDULED FOR ELECTIVE SURGERY FOR REMOVAL OF BREAST LESION/CALCIFICATIONS AND RETAINED METALLIC FRAGMENT/FOREIGN BODY. THE ORIGINAL PACKAGING FOR THE PROBE IN QUESTION WAS NOT KEPT, NOR WAS THE PROBE. DEVICE WAS TRACED BACK TO (B)(6) HOSPITAL-(B)(6)(1383998) BASED OFF THE LOT NUMBER.

  Patient problems: Foreign Body In Patient

  MAUDE report 10601577 ↗

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