LOCalizer HB300-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855436007143), received between Dec 15, 2025 and Jul 27, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Read Input Signal” (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 27, 2026Failure to Read Input Signal

  It was reported that during a LOCalizer procedure on (b)(6) 2026, the "LOCalizer RFID tag would not emit a signal during surgery. Multiple LOCalizer readers and probes were used to troubleshoot." It was further reported that "Radiology confirmed the tag was working prior to placing it and they were able to get a signal of the tag once the specimen was out, and very close to it, but no signal inside the breast." Reporting indicates that in order to identify the tag location, "they had to bring in a C arm during surgery." No patient harm was reported; however, injury MDR is being submitted due to the additional intervention that was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024650 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2025, "PATIENT WITH RIGHT BREAST CANCER UNDERGOING RF [RADIOFREQUENCY] TAG LOCALIZED PARTIAL MASTECTOMY AND SENTINEL NODE BIOPSY. RF TAG PLACED PRIOR TO SURGERY AND TAG SIGNAL CONFIRMED PRIOR TO INCISION. DURING PROCEDURE TAG COULD NOT BE LOCALIZED USING DETECTOR UNIT. SIGNAL WAS DETECTED WITHOUT TAG NUMBER. INTERMITTENTLY THE TAG SIGNAL WITH TAG NUMBER WAS IDENTIFIED. WE ULTIMATELY VISUALIZED THE TAG, AND THE PROBE DID NOT IDENTIFY A SIGNAL WHILE DIRECTLY ON THE TAG. THIS RESULTED IN THE CREATION OF A LARGER LUMPECTOMY SPECIMEN INCLUDING AN ADDITIONAL SUPERIOR MARGIN." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809834 ↗