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LOCalizer HB200-07Recalls & reported problems

Health Beacons, Inc. · Tag Applicator 7 cm, Single · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855436007051), received between Sep 24, 2022 and Sep 24, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2022 DURING A LOCALIZER PROCEDURE, THE LOCALIZER TAG SEEMED TO BE STUCK TO A PLASMABLADE WHILE RESECTING THE TISSUE FROM THE PATIENT. WHEN THE SAMPLE WAS SENT TO THE PATHOLOGY LAB, THE CLIP WAS NOT FOUND IN THE SPECIMEN AREA OF INTEREST FROM WHERE THE TAG WAS REMOVED FROM. THE SURGEON HAD TO GO BACK IN AND TAKE ADDITIONAL SPECIMEN USING THE C-ARM IN ORDER TO GET OUT THE CLIP. THE SURGEON REPORTED THAT SLIGHTLY MORE BREAST TISSUE WAS REMOVED TO FIND THE LESION, THE PATIENT DID REQUIRE ADDITIONAL IMAGING (FLUOROSCOPY TO TRIANGULATE AND FIND THE BIOPSY CLIP).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15480788 ↗

Other Marker, Radiographic, Implantable devices

All Marker, Radiographic, Implantable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.