MammoStar™ STAR1001Recalls & reported problems
Carbon Medical Technologies, Inc. · Biopsy Site Identifier · Class 2 · Implant
All models of MammoStar (11)
Data updated Oct 16, 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 00858015005356), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A RETROSPECTIVE CHART REVIEW STUDY DOCUMENTED A PATIENT WHO DEVELOPED AN INFECTION POSSIBLY ASSOCIATED WITH THE IMPLANTATION PROCEDURE. THE INFECTION OCCURRED WITHIN ONE DAY TO ONE WEEK AFTER IMPLANTATION AND WAS CONSIDERED LIFE-THREATENING. CLINICAL MANAGEMENT REQUIRED OPEN SURGICAL RE-INTERVENTION, AFTER WHICH THE PATIENT MADE A FULL RECOVERY. IT WAS NOTED THAT THE TISSUE MARKER HAD BEEN IMPLANTED IN THE PRESENCE OF A PRE-EXISTING INFECTION AT THE IMPLANTATION SITE.
Patient problems: Post Operative Wound Infection
MAUDE report 23285761 ↗
Other Marker, Radiographic, Implantable devices
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- BioZorb F0221Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
- BioZorb F0203Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls51 reports
- BioZorb F0231Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0303Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0304Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0404Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls6 reports
- BioZorb F0331Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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