MammoStar™ STAR1032Recalls & reported problems
Carbon Medical Technologies, Inc. · Biopsy Site Identifier - Revolve · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858015005370), received between Feb 18, 2021 and Feb 18, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Expulsion” (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
Device problems
- Expulsion1
Patient problems
- Abscess1
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2021Expulsion; Expulsion
IT WAS REPORTED THAT THE PATIENT HAD ONE MAMMOSTAR BIOPSY SITE IDENTIFIER (STAR1032) PLACE AFTER A BIOPSY PROCEDURE APPROXIMATELY 2 YEARS AGO. IN (B)(6) 2020, THE PATIENT CAME TO HOSPITAL BECAUSE THERE WAS A WARM AND RED SPOT ON HER BREAST NEAR THE NIPPLE. THE PHYSICIAN DECIDED TO REMOVE THE SPOT. A LOT OF WHITE/YELLOW LIQUID CAME OUT. THE PHYSICIAN DISCOVERS A "GEL" WITH CERAMIC INSIDE, LOOKING LIKE A MAMMOSTAR. THE ST VAB 2 YRS AGO WAS UNEVENTFUL, THE SCAR IS NOT AT THE SAME AREA OF WHERE THE MARKER CAME OUT.
Patient problems: Abscess; Foreign Body Reaction
MAUDE report 11347044 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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