TriMark TRIMARK TD 3609Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05420045503307), received between Mar 28, 2019 and Aug 6, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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, 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 28, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN DEPLOYING THE MARKER THERE WAS NO MARKER IN THE BIOPSY CAVITY. "WE INVESTIGATED THE DEPLOYMENT DEVICE AND NOTHING WAS FOUND IN SIDE THE DEVICE NEITHER". NO INJURY OR MISDIAGNOSIS WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460806 ↗
• MalfunctionMar 28, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN DEPLOYING THE MARKER THERE WAS NO MARKER IN THE BIOPSY CAVITY. "WE INVESTIGATED THE DEPLOYMENT DEVICE AND NOTHING WAS FOUND IN SIDE THE DEVICE NEITHER". NO INJURY OR MISDIAGNOSIS WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460803 ↗
• MalfunctionMar 28, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN DEPLOYING THE MARKER THERE WAS NO MARKER IN THE BIOPSY CAVITY. "WE INVESTIGATED THE DEPLOYMENT DEVICE AND NOTHING WAS FOUND IN SIDE THE DEVICE NEITHER". NO INJURY OR MISDIAGNOSIS WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460799 ↗