TriMarkRecalls & reported problems across all models

We found 9 models of TriMark by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2017 and Sep 17, 2026 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 reports).

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

Most reported TriMark problems

TriMark models

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

• TriMark TRIMARK TD 3609

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  8 reports
• TriMark TRIMARK-EVIVA-2S-13

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  4 reports
• TriMark TRIMARK TD 13MR

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  2 reports
• TriMark TRIMARKTD-2S-36-09

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  2 reports
• TriMark TRIMARK TD 1309

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report
• TriMark TRIMARKTD-2S-13-09

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report
• TriMark TRIMARKTD-2S-13-12

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report
• TriMark TRIMARKTD-2S-13-MR

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report
• TriMark TRIMARK-EVIVA-13

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report

Recent TriMark adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Fragmentation

  It was reported by the user site that, "During biopsy, radiologist tried to deploy marker. Device shot off like a gun. It deployed the marker, but looks like the metal on inside exploded." Customer outreach confirmed that "metal was sticking out of the side of aperture/hole area" and that this was "only identified when removed from the breast." Despite the reported issue, the marker was successfully deployed and the procedure was completed using the same device. No patient or user harm was reported, and no additional medical or surgical intervention were required due to this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802636 ↗
• InjuryAug 6, 2026Material Fragmentation

  It was reported on July 20, 2026 that during a procedure with a Trimark that "When the marker was used on a patient and inserted into the patient's breast, it opened and came apart, leaving a small piece of the marker inside the patient.". Customer outreach was performed and confirmed the patient did not suffer any additional harm, and there was no additional medical or surgical intervention required as a result of the retained fragment. There are no post-procedure images available and no further information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165687 ↗
• MalfunctionMar 10, 2026Failure to Eject

  IT WAS REPORTED THAT AFTER A VACUUM ASSISTED BREAST BIOPSY, USING AN ATEC NEEDLE AND TRIMARK BREAST MARKER, NO MARKER WAS OBSERVED IN THE PATIENT'S BREAST TISSUE IN THE POST PROCEDURE MAMMOGRAM. IT IS REPORTED THAT THE MARKER DEPLOYMENT PROCEDURE WAS NOT COMPLETED. NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562651 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, AN ARTIFACT WAS OBSERVED IN THE PATIENT'S BREAST AFTER AN MRI BIOPSY IN ADDITION TO THE TRIMARKTD-2S-13-MR MARKER THAT WAS DEPLOYED AT THE TIME. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE CUSTOMER REPORTS THAT THE PATIENT REQUIRED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22031090 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, AN ARTIFACT RESEMBLING METAL WAS OBSERVED IN THE PATIENT´S BREAST AFTER A MRI BIOPSY IN ADDITION TO THE MARKER (TRIMARK MARKER) THAT WAS DEPLOYED AT THE TIME. THE RADIOLOGIST RECOMMENDED THE PATIENT TO HAVE THE SURGERY TO HAVE THE MATERIAL REMOVED AND THE BIOPSY WAS BENIGN. NO ISSUES WERE REPORTED DURING SET UP AND PATIENT RECEIVED ANOTHER MAMMOGRAM ON (B)(6) 2025 DUE TO ARTIFACT. SURGERY IS SCHEDULED FOR (B)(6) 2025. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21989622 ↗
• MalfunctionDec 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2024, FOLLOWING A PATIENT´S OPERATION AN X-RAY OF THE SPECIMEN REMOVED FROM THE PATIENT, REVEALED THAT A PIECE OF THE MATERIAL USED TO INSERT THE CLIP WAS ALSO PRESENT IN THE TUMOR ADDITIONALLY TO THE CLIP. THE PIECE OF MATERIAL WAS THERE SINCE IMPLANTATION ON (B)(6) 2024. THERE WERE NO NOTICEABLE INCIDENTS DURING THE EXAMINATION APART SOME RESISTANCE WHEN REMOVING THE MATERIAL TO INSERT THE CLIP. NO PATIENT INJURY REPORTED AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20835876 ↗
• InjuryMar 8, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6), WAS NOTICED THAT THE TRIMARK TD MIGRATED FROM THE LOCATION WHERE IT WAS INSERTED, IN TWO SEPARATE OCCURRENCES. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866464 ↗
• InjuryJun 16, 2023Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT ON MAY 22TH A STEREO BIOPSY PROCEDURE WAS PERFORMED AND WHEN PLACING THE MARKER, IT WAS NOT FOUND. A MAMMOGRAPHY VIEW IS PERFORMED TO CONFIRM IF THE MARKER IS PRESENT, BUT IT WAS NOT VISUALIZED. A SECOND INCISION WAS DONE TO INTRODUCE ANOTHER MARKER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143625 ↗
• InjuryApr 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT RECEIVED A TRIMARK MARKER AND AFTER THE PROCEDURE DEVELOPED A SKIN RASH. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Rash

  MAUDE report 16733328 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THAT USED A TRIMARK FOR EVIVA , AFTER IMPLANTATION OF THE CLIP A CIRCULAR HYPERDENSITY WAS OBSERVED BEHIND THE CLIP, NO INJURY TO THE PATIENT WAS REPORTED, PATIENT DID NOT REQUIRED ADDITIONAL MEDICATION, IMAGING OR SURGERY, THE RESULTS OF THE BIOPSY WERE REPORTED AS BENING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14364411 ↗
• MalfunctionJul 6, 2021Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT, DURING A BIOPSY PROCEDURE, WHEN PLACING THE BIOPSY MARKER THE RADIOLOGIST DEPLOYED THE MARKER AS USUAL. WHEN THE MARKER DEVICE WAS REMOVED FROM THE BREAST IT WAS NOTED THE MARKER WAS STUCK IN THE APERTURE. REDEPLOYMENT WAS NOT ATTEMPTED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122419 ↗
• MalfunctionApr 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER DEPLOYING THE BIOPSY SITE IDENTIFIER, POST BIOPSY MAMMOGRAPHY IMAGES WERE OBTAINED. THE RADIOLOGIST NOTED WHAT APPEARS TO BE A METALLIC FOREIGN BODY IN THE IMAGES THAT DOES NOT CORRELATE TO THE SITE MARKER AND WAS NOT SEEN ON POST BIOPSY IMAGING. THE REPORTED DEVICE HAS BEEN REQUESTED TO RETURN TO HOLOGIC FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11628666 ↗
• InjuryDec 7, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AT THE END OF AN X-RAY GUIDED VAB, THE CANNULA OF THE BIOPSY MARKER SITE SYSTEM WAS INSERTED, FOLLOWING THE NORMAL PROCEDURE. DURING THE DEPLOYMENT OF THE MARKER CLIP, WHILE PRESSING THE PLUNGER, AS RECOMMENDED, THE USER REALIZED THAT THE CANNULA OF THE DEVICE WAS SHORTENED AND THE PATIENT EXPERIENCED PAIN. MAMMOGRAPHIC VIEWS FOLLOWED, WHICH SHOWED THAT A PART FROM THE MARKER CLIP, A BROKEN PART (17MM) OF THE DISTAL END OF THE DEVICE WAS VISUALISED WITHIN THE BREAST, NEXT TO THE CLIP. THE DEVICE WAS REMOVED AND THE USER CONFIRMED THAT THERE WAS A MISSING PART OF THE CANNULA. BROKEN PART OF THE CANNULA DEVICE REMAINED WITHIN THE BREAST AND AN UNNECESSARY OPERATION MIGHT BE REQUIRED TO REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10958495 ↗
• MalfunctionAug 2, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER DEPLOYING THE MARKER, THERE WAS NO CLIP SEEN ON POST BIOPSY IMAGES. THE MARKER COULD NOT BE FOUND ANYWHERE. IT IS ASSUMED THAT THERE WAS NO MARKER INSIDE THE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855641 ↗
• MalfunctionApr 24, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, "THE CLIP DID NOT COME OUT DURING THE PROCEDURE." NO INJURY OR MISDIAGNOSIS REPORTED. A SECOND DEVICE WAS USED AND A SITE MARKER WAS SUCCESSFULLY PLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545478 ↗

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