MammoStarRecalls & reported problems across all models

We found 11 models of MammoStar by Carbon Medical Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and May 22, 2026 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MammoStar recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 16, 2022Terminated

   The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.

   Z-1041-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported MammoStar problems

MammoStar models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MammoStar™ STAR1402

  Marker, Radiographic, Implantable
  1 recall1 report
• MammoStar™ STAR1401

  Marker, Radiographic, Implantable
  4 reports
• MammoStar™ STAR0831

  Marker, Radiographic, Implantable
  3 reports
• MammoStar™ STAR0832

  Marker, Radiographic, Implantable
  1 report
• MammoStar™ STAR0833

  Marker, Radiographic, Implantable
  1 report
• MammoStar™ STAR1001

  Marker, Radiographic, Implantable
  1 report
• MammoStar™ STAR1031

  Marker, Radiographic, Implantable
  1 report
• MammoStar™ STAR1032

  Marker, Radiographic, Implantable
  1 report
• MammoStar™ STAR1101

  Marker, Radiographic, Implantable
  1 report
• MammoStar™ STAR1102

  Marker, Radiographic, Implantable
  1 report
• MammoStar™ STAR1121

  Marker, Radiographic, Implantable
  1 report

Recent MammoStar adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT AN INFECTION WAS OBSERVED WITH A PROBABLE ASSOCIATION. CLINICAL MANAGEMENT INCLUDED TOPICAL MEDICATION, PATIENT OUTCOME IS UNKNOWN. THE PROCEDURE WAS CARRIED OUT DESPITE THE PRESENCE OF AN INFECTION, WHICH IS A KNOWN RISK FACTOR.

  Patient problems: Unspecified Infection

  MAUDE report 19399290 ↗
• InjuryMay 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT AN IMMUNE RESPONSE WAS OBSERVED WITH A CAUSAL ASSOCIATION. CLINICAL MANAGEMENT INCLUDED TOPICAL MEDICATION RESULTING IN A FULL RECOVERY. THE PROCEDURE WAS CARRIED OUT DESPITE THE PRESENCE OF AN INFECTION, WHICH IS A KNOWN RISK FACTOR. DESPITE A WARNING IN THE IFU, THE MARKER WAS INSERTED INTO A BLOOD VESSEL.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19399287 ↗
• InjuryMay 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT A FOREIGN BODY REACTION WAS OBSERVED WITH A PROBABLE ASSOCIATION. CLINICAL MANAGEMENT INCLUDED SURGERY RESULTING IN A PARTIAL RECOVERY. IT WAS NOTED THAT THE TISSUE MARKER WAS USED IN THE PRESENCE OF A BREAST IMPLANT. THE PROCEDURE WAS CARRIED OUT DESPITE THE PRESENCE OF AN INFECTION, WHICH IS A KNOWN RISK FACTOR.

  Patient problems: Foreign Body Reaction

  MAUDE report 19399286 ↗
• InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT A REVISION SURGERY WAS OBSERVED WITH A PROBABLE ASSOCIATION. CLINICAL MANAGEMENT INCLUDED SURGERY RESULTING IN A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399251 ↗
• InjuryMay 27, 2024Patient-Device Incompatibility; Prophylactic removal due to corrective action; Patient-Device Incompatibility; Prophylactic removal due to corrective action

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT AN FOREIGN BODY REACTION WAS OBSERVED WITH A CAUSAL ASSOCIATION. CLINICAL MANAGEMENT INCLUDED ORAL MEDICATION RESULTING IN A FULL RECOVERY. DESPITE A WARNING IN THE IFU, THE MARKER WAS INSERTED INTO A BLOOD VESSEL.

  Patient problems: Foreign Body Reaction

  MAUDE report 19399249 ↗
• InjuryMay 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A RETROSPECTIVE CHART REVIEW POST MARKET CLINICAL FOLLOW-UP STUDY REPORTED THAT HYPERSENSITIVITY WAS OBSERVED WITH A PROBABLY ASSOCIATION TO THE DEVICE OR PROCEDURE. CLINICAL MANAGEMENT WAS NOT REPORTED RESULTING IN A PARTIAL RECOVERY. IT WAS ALSO NOTED THAT THE PROCEDURE WAS CARRIED OUT DESPITE THE PRESENCE OF AN INFECTION, WHICH IS A KNOWN RISK FACTOR.

  Patient problems: Local Reaction

  MAUDE report 19387896 ↗
• MalfunctionDec 1, 2023Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  DURING CLIP DEPLOYMENT INTO BREAST POST BIOPSY, TIP OF MICROMARKER DEVICE BECAME LODGED INTO TISSUE. TIP HAD TO BE MANUALLY REMOVED. POST MAMMOGRAM SHOWED NO CLIP MIGRATION OR HEMATOMA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18248150 ↗
• MalfunctionJan 25, 2023Migration or Expulsion of Device

  MAMMOSTAR BIOPSY MARKERS ARE MIGRATING WITHIN THE BREAST TISSUE OF PATIENTS FOLLOWING THEIR PLACEMENT WITH A BREAST TISSUE BIOPSY. AS A RESULT, PATIENTS PRESENT IN FOLLOW-UP WITH THEIR ORIGINAL BIOPSY SITE MARKERS IMPROPERLY PLACED. MANUFACTURER SENT A NEW MODEL.

  Patient problems: Insufficient Information

  MAUDE report 16239991 ↗
• 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 ↗
• InjuryNov 19, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS AFTER DEPLOYMENT OF THE MAMMOSTAR MARKER, THE PATIENT REPORTED THAT THE INCISION SITE HAD BEEN REOPENED AND THE MARKER CAME OUT.

  Patient problems: Foreign Body Reaction

  MAUDE report 10871794 ↗
• MalfunctionMar 23, 2020Failure to Advance

  DEVICE FAILED TO DEPLOY AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864743 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER DEPLOYMENT THE MARKER MOVED SUPERFICIAL UNDER THE SKIN. THIS, IN THE CUSTOMER OPINION, CAUSED AN INFECTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 7685479 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER DEPLOYMENT THE MARKER MOVED SUPERFICIAL UNDER THE SKIN. THIS, IN THE CUSTOMER OPINION, CAUSED AN INFECTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 7685472 ↗