LOCalizer HB200-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00855436007044), received between Apr 26, 2022 and Jun 16, 2023 — classified as 2 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2022 THE PATIENT HAD A LOCALIZER TAG BUT WHEN THE MARKER LESION WAS REMOVED AND SENT TO PATHOLOGY THE SAMPLE DID NOT CONTAIN THE CANCER. THE PATIENT RETURNED FOR A NEW PROCEDURE TO MARK THE CANCER AGAIN AND REQUIRED TO REMOVE NEW TISSUE AND A SECOND SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148536 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT RECEIVED A LOCALIZER TAG AND THE CUSTOMER REPORTED THAT THE MARKER MIGRATED FOR UNKNOWN REASONS AND WHEN THEY PERFORMED THE SURGERY THEY WERE NOT ABLE TO FIND THE MARKER, WHICH LEAD TO A SIGNIFICANT HEMATOMA AT THE SURGERY SITE, THE PATIENT REQUIRED ADDITIONAL PROCEDURE TO MARK THE THE CANCER SITE AGAIN AND HAD TO REPEAT THE SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 17148535 ↗
• MalfunctionApr 26, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2022, THE TAG BROKE SOMETIME BETWEEN THE PLACEMENT AND THE SURGERY. NO INJURY TO THE PATIENT WAS REPORTED, THE DEVICE BROKE SOMETIME AFTER THE TAG PLACEMENT, THE MAMMOGRAPHY AFTER THE PLACED LOOKED NORMAL. THE PROCEDURE WAS COMPLETED AND NO ADDITIONAL PROCEDURES REQUIRED AT THE MOMENT. AN IMAGE PROVIDED COULD SEE THE TAG BROKEN ON THE SPECIMEN REMOVED. NO OTHER INFORMATION AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209529 ↗