Mammotome revolve MammoMark MMK1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841911101628), received between Feb 28, 2019 and Apr 17, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT THE APPLICATOR TIP SHEARED OFF IN THE BIOPSY CAVITY AFTER THE MARKER WAS DEPLOYED. THE MAMMOMARK WAS PLACED DURING AN UPRIGHT ST PROCEDURE USING THE REVOLVE 10G PROBE. THE DOCTOR ENCOUNTERED RESISTANCE WHILE INSERTING THE MARKER INTO THE PROBE UNTIL IT REACHED THE COLORED DEPTH INDICATOR BAND. DESPITE THIS, THEY CONTINUED TO PUSH THE MARKER TO THE END OF THE PROBE, AT WHICH POINT THEY NOTICED THAT THE APERTURE WAS CLOSED. ONCE THE APERTURE WAS FULLY OPENED, THE MARKER WAS SUCCESSFULLY INSERTED. THE TIP OF THE MARKER APPLICATOR WAS VISIBLE IN THE BIOPSY CAVITY ON THE POST-PROCEDURE IMAGES. TWO REQUESTS WERE MADE ASKING FOR POST-FILMS; THERE WAS NO RESPONSE. THE MARKER APPLICATOR WAS DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24915683 ↗
• InjuryOct 15, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS A TIP SHEAR OF MMK1002 MARKER. THE TIP WAS LEFT INSIDE OF THE BREAST AND DISCOVERED IN POST-BIOPSY IMAGING. RADIOLOGIST CONFIRMED THAT THE APERTURE WAS FULLY OPEN DURING DEPLOYMENT. THE PROBLEM OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED MMK1002. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23280209 ↗
• InjuryFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A USER MEDWATCH STATING, "(B)(6) 2018 MAMMOGRAM STEREOTACTIC RIGHT BREAST BIOPSY FOR INDETERMINATE RIGHT BREAST MICROCALCIFICATIONS, MULTIPLE PASSES WERE MADE UNDER ULTRASOUND GUIDANCE USING A VACUUM ASSISTED 10-GUAGE ELITE DEVICE. A TITANIUM CLIP WAS PLACED AT BIOPSY SITE. SPECIMEN WAS SENT TO PATHOLOGY FOR REVIEW. MICROCALCIFICATIONS WERE NOTED IN THE SPECIMEN RADIOGRAPH. POST STEREOTACTIC BIOPSY RIGHT BREAST MAMMOGRAM CONFIRMED TITANIUM CLIP WAS IN THE APPROPRIATE LOCATION. IN ADDITION, ON THE RIGHT MLO VIEW, A 12X2.4 MM CYLINDRICAL STRUCTURE, WHICH LIKELY CORRESPONDED TO THE RADIOPAQUE TIP OF THE MAMMOTOME MARK WHICH SHEARED OFF DURING THE PROCEDURE, LOCATED APPROX 7CM PROXIMAL TO THE TITANIUM CLIP, SUPERFICIALLY. THE PT WAS INFORMED OF THE SHEARED MAMMOMARK CATHETER TIP AND CONCURRED WITH THE SURGEON'S PLAN TO LEAVE THE TIP IN PLACE. THE SURGICAL PATHOLOGY REPORT REVEALED BENIGN MICROCALCIFICATIONS. THE PT HAD NO COMPLAINTS OF PAIN UNTIL (B)(6) 2018. ON (B)(6) 2018, THE PT UNDERWENT EXPLORATION AND REMOVAL OF FOREIGN BODY IN RIGHT BREAST UNDER LOCAL ANESTHESIA PLUS SEDATION. THE TIP OF THE MAMMOTOME WAS TAKEN OUT AND SENT TO PATHOLOGY. O

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8379864 ↗