Mammotome revolve CA000399017Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841911102731), received between Jan 31, 2025 and Mar 6, 2026 — classified as 1 injury, 5 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026

  FAULTY NEEDLE FOR BIOPSY NEEDLE WOULD NOT LOCK TO MACHINE NEEDLE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531718 ↗
• MalfunctionJan 7, 2026

  WHEN SETTING UP NEEDLE, TONGUE AND GROOVE PIECE OF NEEDLE THAT ATTACHÉS TO OUR HOLSTER WAS CROOKED- WOULD NOT LINE UP WITH THE GROOVES TO SNAP INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990430 ↗
• MalfunctionOct 31, 2025Leak/Splash

  SET UP VACUUM ASSISTED NEEDLE FOR BIOPSY AND SALINE STARTED POURING OUT OF THE CONNECTED TUBE TO THE DEVICE. CHECKED SALINE SPIKE WAS NOT COMING FROM THERE, LOOKED LIKE A LEAK WHERE THE CONNECTER CONNECTS TO THE TUBE THAT SALINE RUNS THROUGH FROM THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 23435704 ↗
• MalfunctionJul 8, 2025Break; Connection Problem

  UNABLE TO ATTACH STEREOTACTIC BIOPSY NEEDLE TO HOLDER TO PERFORM BIOPSY. GEAR ON NEEDLE APPEARS TO BE BROKEN/FAULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435841 ↗
• MalfunctionMar 6, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING THE PROCEDURE THERE WAS AN INCIDENT OF FOREIGN BODY OF UNKNOWN ORIGIN IN RELATION TO THIS EQUIPMENT. THIS HAS RESULTED IN THIS EQUIPMENT BEING REMOVED FROM CLINICAL USE WITH IMMEDIATE EFFECT. CLIENT ATTENDED (B)(6)2025 FOR AN INITIAL 14G BIOPSY (HANDHELD BIOPSY DEVICE). AN ULTRACLIP MARKER WAS INSERTED DURING THIS PROCEDURE. THE PATHOLOGY RESULTS WERE B1 SO A FURTHER BIOPSY WAS ARRANGED FOR THIS MORNING. THIS REPEAT BIOPSY WAS PERFORMED WITH 10G NEEDLE ON THE MAMMOTOME VACUUM ASSISTED BIOPSY EQUIPMENT. 4 CORES WERE TAKEN AND UPON X-RAY EXAMINATION OF THESE A FOREIGN BODY WAS DISCOVERED WITHIN THE CORE. THIS HAS A CORKSCREW APPEARANCE AND IS NOT OF THE SAME SIZE OR SHAPE AS THE ULTRACLIP MARKER THAT WAS ALREADY IN SITU FROM PREVIOUS BIOPSY. THE ENTIRE MAMMOTOME NEEDLE SYSTEM WAS REMOVED FROM THE PATIENT AND A HYDROMARK CLIP WAS DEPLOYED (THIS IS A DIFFERENT SIZE AND SHAPE FROM ULTRACLIP TO ALLOW US TO DIFFERENTIATE BETWEEN THE 2 CLIPS). POST CLIP X-RAYS WERE TAKEN AND BOTH MARKERS ARE SEEN FULLY INTACT ON THE IMAGE. FROM ANALYSIS OF THE INITIAL X-RAYS, THERE WAS NO PREVIOUS METAL WORK IN THE CLIENT'S BREAST THAT COULD ACCOUNT FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535769 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, METAL SHARDS WERE RETAINED WITHIN THE PATIENT AFTER COMPLETION OF THE BIOPSY. THE SHARDS ARE SEEN POST-MAKER PLACEMENT ON BOTH CRANIAL CAUDAL AND MEDIOLATERAL OBLIQUE POST-FILMS. IN THE MAMMOGRAPHY SLICES, THEY ARE SEEN ON THE 3RD AND 6TH SLICES. THE SHARDS ARE NOT IN THE BIOPSY CAVITY BUT ON THE SUPERFICIAL SKIN SURFACE. THE PROBLEM OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED MST1012.

  Patient problems: Foreign Body In Patient

  MAUDE report 21287177 ↗

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