CELEROMARKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05420045503376), received between Apr 29, 2025 and Dec 22, 2025 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A MEDICAL IMAGING CASE LETTER THAT WAS SUBMITTED ON (B)(6) 2020, TO THE JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY THAT, AN ULTRASOUND GUIDED VACUUM ASSISTED EXCISION BIOPSY, WAS PERFORMED ON A 60-YEAR-OLD WOMAN ON AN UNKNOWN DATE, USING A 7G ENCORE PROBE AND ENCOR ENSPIRE BREAST BIOPSY SYSTEM. IT IS REPORTED THAT "A DUMBBELL-SHAPED BREAST BIOPSY MARKER," (B)(6) WAS INSERTED; HOWEVER, "MAMMOGRAPHY SHOWED AN AIR-FILLED CAVITY AT THE LESION SITE, COMPLETE REMOVAL OF THE RESIDUAL LESION/TWIRL MARKER AND THE DUMBBELL-SHAPED BREAST BIOPSY MARKER SEVERAL CENTIMETERS FROM THE SITE." IT WAS FURTHER REPORTED THAT "ANOTHER BREAST BIOPSY MARKER, CYLINDRICAL-SHAPED CELEROMARK WAS PLACED TARGETING THE CAVITY; HOWEVER, INACCURATE POSITIONING/MIGRATION WAS AGAIN SEEN." MALFUNCTION MDR IS BEING SUBMITTED DUE TO THE REPORTED MARKER MIGRATION. HOLOGIC AWARENESS OF THIS CASE LETTER WAS NOVEMBER 24, 2025. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23869624 ↗
• InjuryApr 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CELEROMARK PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT ON THE POST ULTRASOUND GUIDED BREAST BIOPSY THE MARKER COULD BE OBSERVED DEPLOYED. THE PATIENT WAS SENT FOR MAMMOGRAM IN SITU. WHILE REVIEWING THE IMAGE ONLY THE PREVIOUS CLIPS WERE VISIBLE AND THE MARKER COULD NOT BE OBSERVED. PATIENT WAS LATER RECALLED FOR ANOTHER IMPLANTATION AND ANOTHER MARKER. PHYSICIAN REPORTED THAT THE FIRST PROCEDURE WAS A SMALL POCKET OF GAS (¨PSEUDO CLIP¨) WHICH COULD NOT BE DIFFERENTIATED. ANOTHER MARKER WAS IMPLANTED ON A SEPARATE INCISION AND CONFIRMED IMPLANTATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931524 ↗