LOCalizer HB110Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00855436007013), received between Feb 17, 2022 and Apr 8, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Material Fragmentation

  IT WAS REPORTED BY THE USER SITE THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2026, THE "WHITE THREADS AT THE TIP OF PROBE CAME OFF AND WENT INTO PATIENT." IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THE "WHITE THREADS" WERE REMOVED FROM THE PATIENT BEFORE THE INCISION WAS CLOSED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24818149 ↗
• InjuryOct 3, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6), THAT A LOCALIZER TAG WAS ERODING THROUGH THE SKIN AWAY FROM THE MARKER'S INCISION. THE RFID TAG WAS PLACED VERY SUPERFICIALLY AND THE TAG WAS NOT ERODING THROUGH THE PREVIOUS INCISION. THE DOCTOR REMOVED ADDITIONAL SKIN ALONG WITH THE BREAST TISSUE BIOPSY, THE TAG STILL WORKED AS IT SHOULD AND THE PROCEDURE WAS STILL A SUCCESS. THE TAG WAS PLACED VERY SUPERFICIALLY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erosion

  MAUDE report 20363809 ↗
• MalfunctionMar 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ON FEBRUARY 7TH, A PROCEDURE WITH A LOCALIZER WAS PERFORMED AND THE SURGICAL PROBE WAS GIVING INCONSISTENT READINGS WHILE THE PATIENT ALREADY HAD AN INCISION DONE. THE DOCTOR DID NOT TRUST THE DEVICE. THERE WAS NO PHYSICAL HARM TO THE PATIENT; THEY HAD TO RESCHEDULE THE SURGERY, AND THE PATIENT WOULD HAVE TO RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466926 ↗
• MalfunctionMar 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ON FEBRUARY 7TH, A PROCEDURE WITH A LOCALIZER WAS PERFORMED AND THE SURGICAL PROBE WAS GIVING INCONSISTENT READINGS WHILE THE PATIENT ALREADY HAD AN INCISION DONE. THE DOCTOR DID NOT TRUST THE DEVICE. THERE WAS NO PHYSICAL HARM TO THE PATIENT; THEY HAD TO RESCHEDULE THE SURGERY, AND THE PATIENT WOULD HAVE TO RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466894 ↗
• InjuryOct 17, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON SEPTEMBER 14TH , THE LOCALIZER SURGICAL PROBE WAS ACTING UP AND GIVING INACCURATE READINGS. THE PROBE WAS EXCHANGED BUT NO RELIABLE READINGS. THE PHYSICIAN REPORTED THEY ENDED UP REMOVING TWICE THE AMOUNT OF TISSUE DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616640 ↗
• InjuryOct 12, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6), THE LOCALIZER SURGICAL PROBE WAS ACTING UP AND GIVING INACCURATE READINGS. THE PROBE WAS EXCHANGED BUT NO RELIABLE READINGS. THE PHYSICIAN REPORTED THEY ENDED UP REMOVING TWICE THE AMOUNT OF TISSUE DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588125 ↗
• InjuryFeb 17, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2021, THE READER WAS RECEIVING INACCURATE READINGS, AND THE PHYSICIAN HAD TO EXCISE ADDITIONAL TISSUE FROM THE PATIENT DUE TO THIS EVENT. THE PROCEDURE WAS PROLONGED DUE TO THIS EVENT AND THE PATIENT HAD TO BE KEPT UNDER ANESTHESIA FOR ADDITIONAL 40 MINUTES. THE PROCEDURE WAS COMPLETED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551093 ↗