MammoStar™ STAR0833Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858015005349), received between May 22, 2026 and May 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 22, 2026Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  DURING A STEREOTACTIC BIOPSY USING MAMMOTOME REVOLVE WITH A SIEMENS UPRIGHT, THE RADIOLOGIST ENCOUNTERED TIP SHEAR WITH (1) STAR0833. THE RADIOLOGIST FIRST USED MMK0801. THE MARKER WAS DEPLOYED, BUT THEY WERE UNABLE TO SEE IT IN THE BREAST. IT COULD HAVE BEEN SUPERIMPOSED BEHIND THE PROBE. THE PHYSICIAN THEN DECIDED TO ADD A SECOND CLIP AND CHOSE TO USE STAR0833. HOWEVER, DURING DEPLOYMENT, THE MARKER BECAME STUCK IN THE CHAMBER, AND WHEN THEY TRIED TO PULL THE DEPLOYMENT DEVICE OUT, IT WAS STUCK IN THE BREAST. AT THE VERY END OF THE MARKER DEPLOYMENT DEVICE, THE WHITE TIP WAS PULLED OFF JUST ENOUGH THAT THE "FORK"- LOOKING END CAUGHT THE BREAST TISSUE, AND THEY WERE UNABLE TO PULL THE DEVICE BACK OUT. THE PHYSICIAN HAD TO MAKE AN ADDITIONAL INCISION ON THE BREAST TO WIDEN THE AREA TO BE ABLE TO PULL THE DEVICE OUT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25259369 ↗