SCOUT Bx™ 00884450719596Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450719596), received between Jan 20, 2026 and Jan 27, 2026 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026

  PATIENT WAS HERE FOR A LEFT BREAST BIOPSY WITH A SAVI SCOUT PLACEMENT. BIOPSY WAS SUCCESSFUL. UPON DEPLOYING THE SAVI SCOUT AT 11:41 AM, IT WAS NOT DEFINITIVELY VISUALIZED WITH ULTRASOUND. MAMMO IMAGING CONFIRMED THAT THE SAVI SCOUT REFLECTOR WAS NOT PRESENT. PATIENT CAME BACK TO THE ULTRASOUND DEPT TO ATTEMPT ANOTHER SAVI SCOUT PLACEMENT. SECOND ATTEMPT WAS SUCCESSFUL. PATIENT RETURNED TO THE MAMMO DEPT FOR CONFIRMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24188621 ↗
• MalfunctionJan 20, 2026

  PATIENT WAS HERE FOR A LEFT BREAST BIOPSY WITH A SAVI SCOUT PLACEMENT. BIOPSY WAS SUCCESSFUL. UPON DEPLOYING THE SAVI SCOUT AT 11:41 AM, IT WAS NOT DEFINITIVELY VISUALIZED WITH ULTRASOUND. MAMMO IMAGING CONFIRMED THAT THE SAVI SCOUT REFLECTOR WAS NOT PRESENT. PATIENT CAME BACK TO THE ULTRASOUND DEPT TO ATTEMPT ANOTHER SAVI SCOUT PLACEMENT. SECOND ATTEMPT WAS SUCCESSFUL. PATIENT RETURNED TO THE MAMMO DEPT FOR CONFIRMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115046 ↗