Tuloc 271661Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250195600844), received between Apr 14, 2023 and Jul 22, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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.

• InjuryJul 22, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A MARKING OF BREAST LESION USING A TULOC DEVICE, A PATIENT HAD TO BE OPERATED ON TWICE, DUE TO THE DEVICE DISLOCATED AND WAS BEING STUCK IN THE INCORRECT POSITION. BETWEEN THE 1ST AND 2ND PROCEDURE APPROXIMATELY 6 WEEKS TRANSPIRED. THE WIRE COULD NOT BE REMOVED FROM THE PATIENT IN QUESTION AS IT HAD SHORTENED AFTER BEING IN THE FIRST POSITION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795362 ↗
• InjuryApr 14, 2023Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, AFTER A BREAST BIOPSY THE PHYSICIAN ATTEMPTED TO IMPLANT A TULOC HARPOON, THE PHYSICIAN REPORTED THAT HE HAD TO READJUST THE HARPOON AND ON THE CONTROL MAMMOGRAM IT WAS OBSERVED A SMALL CYLINDER INSIDE THE BREAST THAT HAD DETACHED FROM THE HARPOON. THE PHYSICIAN VERIFIED THE PROPER FUNCTIONING OF THE HARPOON BEFORE USING IT. DURING TRACKING HE REMOVED THE HARPOON TO READJUST ITS POSITION WITHOUT ANY PARTICULAR TECHNICAL PROBLEM. HOWEVER ON THE FOLLOW UP MAMMOGRAM IT WAS FOUND THAT A 17MM LINEA METAL WAS STUCK INSIDE THE BREAST. IT WAS NOT THERE BEFORE REMOVAL. THE HARPOON WAS CHECKED AND A SMALL CYLINDRAL PIECE WAS MISSING FROM THE END OF THE WIRE. THE DEVICE WAS RETURNED FOR EXAMINATION AND IT WAS CONFIRMED THAT A SMALL PIECE WAS MISSING FROM THE END SECTION OF THE DEPLOYER. A FOLLOW UP WITH THE PHYSICIAN REVEALED THAT THE PATIENT WAS NOT AFFECTED BY THE PROCEDURE AND IN A SUBSEQUENT SURGERY ALREADY PLANED TO REMOVE THE PATHOLOGY THE METAL CYLINDER WAS REMOVED AS WELL. NO MORE TISSUE REQUIRED TO BE REMOVED FROM THE PATIENT AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. A FOLLOW UP MAMMOGRAM IS SCHEDULED FOR (B)(6) 2023. NO OTHER INFORMATION I

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742843 ↗