LOCalizer HB100Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00855436007037), received between Aug 12, 2021 and May 5, 2026 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA AN ANONYMOUS SURVEY THAT AFTER THE USE OF A LOCALIZER DEVICE ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. IT IS REPORTED THAT THE ADDITIONAL INTERVENTION OF DRAINING THE AREA WAS REQUIRED. DUE TO THE UNAVAILABILITY OF USER SITE INFORMATION, ADDITIONAL CLARIFYING DETAILS COULD NOT BE OBTAINED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 25085341 ↗
• MalfunctionMar 30, 2026Incorrect Interpretation of Signal; Migration

  IT WAS REPORTED BY THE USER SITE THAT DURING A LOCALIZER PROCEDURE ON (B)(6), 2025, THE USER OBSERVED THAT THE READERS WERE "GOING OFF CONSTANTLY" EVEN WHEN THEY WERE NOT NEAR A CLIP, AND THERE WERE COMPLAINTS FROM THE SURGEON REGARDING CLIP MIGRATION ISSUES. NO USER OR PATIENT INJURIES WERE REPORTED. THE USER SITE REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716142 ↗
• InjuryFeb 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A LOCALIZER LUMPECTOMY PROCEDURE ON (B)(6) 2026, THE RADIOFREQUENCY CLIP IDENTIFICATION NUMBER WAS NOT REFLECTING ON THE DEVICE WHEN ATTEMPTING TO LOCATE THE CLIP DURING THE PROCEDURE. THE USER REPORTS THAT "THE INACCURACY OF THIS DEVICE CAUSED THIS PATIENT TO HAVE MORE BREAST TISSUE REMOVED THAT WAS LIKELY NECESSARY." IT IS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261258 ↗
• InjuryJan 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Migration

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2026, THE USER REPORTED THAT "THE SIGNAL IS SCATTERED AND WILL DETECT A ¿SIGNAL¿ RANDOMLY THAT HAS ABSOLUTELY NO CONCORDANCE WITH THE CLIP." AFTER OBTAINING ADDITIONAL INFORMATION FROM THE USER, IT WAS FURTHER REPORTED THAT THE SURGICAL PROCEDURE TOOK LONGER THAN NORMAL AND REQUIRED "MORE DISSECTION TRYING TO FIND THE TAG." THE USER REPORTS THAT THE TAG HAD "MIGRATED TO THE SKIN AS IT WAS NOT WITH THE MASS THAT WAS REMOVED." THE USER HAS CONFIRMED THAT THE LOCALIZER TAG WAS LOCATED AND REMOVED FROM THE PATIENT WITHOUT REMOVING ADDITIONAL BREAST TISSUE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190015 ↗
• MalfunctionJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Migration

  IT WAS REPORTED BY THE USER THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED ISSUES WITH THE DEVICE "GOING OFF CONSTANTLY" EVEN WHEN IT IS NOT NEAR A CLIP. ADDITIONALLY, THE USER REPORTED THAT CLIP MIGRATION ISSUES HAVE BEEN EXPERIENCED. MALFUNCTION MDR SUBMITTED DUE TO REPORTS OF CLIP MIGRATION. THE USER REPORTS FOUR IMPACTED DEVICES; THEREFORE, A SEPARATE MDR WILL BE SUBMITTED FOR EACH DEVICE. NO PATIENT/USER INJURY HAS BEEN REPORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059301 ↗
• MalfunctionJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Migration

  IT WAS REPORTED BY THE USER THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED ISSUES WITH THE DEVICE "GOING OFF CONSTANTLY" EVEN WHEN IT IS NOT NEAR A CLIP. ADDITIONALLY, THE USER REPORTED THAT CLIP MIGRATION ISSUES HAVE BEEN EXPERIENCED. MALFUNCTION MDR SUBMITTED DUE TO REPORTS OF CLIP MIGRATION. THE USER REPORTS FOUR IMPACTED DEVICES; THEREFORE, A SEPARATE MDR WILL BE SUBMITTED FOR EACH DEVICE. NO PATIENT/USER INJURY HAS BEEN REPORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059189 ↗
• MalfunctionJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Migration

  IT WAS REPORTED BY THE USER THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED ISSUES WITH THE DEVICE "GOING OFF CONSTANTLY" EVEN WHEN IT IS NOT NEAR A CLIP. ADDITIONALLY, THE USER REPORTED THAT CLIP MIGRATION ISSUES HAVE BEEN EXPERIENCED. MALFUNCTION MDR SUBMITTED DUE TO REPORTS OF CLIP MIGRATION. THE USER REPORTS FOUR IMPACTED DEVICES; THEREFORE, A SEPARATE MDR WILL BE SUBMITTED FOR EACH DEVICE. NO PATIENT/USER INJURY HAS BEEN REPORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058909 ↗
• MalfunctionJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Migration

  IT WAS REPORTED BY THE USER THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED ISSUES WITH THE DEVICE "GOING OFF CONSTANTLY" EVEN WHEN IT IS NOT NEAR A CLIP. ADDITIONALLY, THE USER REPORTED THAT CLIP MIGRATION ISSUES HAVE BEEN EXPERIENCED. MALFUNCTION MDR SUBMITTED DUE TO REPORTS OF CLIP MIGRATION. THE USER REPORTS FOUR IMPACTED DEVICES; THEREFORE, A SEPARATE MDR WILL BE SUBMITTED FOR EACH DEVICE. NO PATIENT/USER INJURY HAS BEEN REPORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058645 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DEVICE WAS REPORTING INCONSISTENT READINGS. DUE TO THE ISSUE THE PHYSICIAN REMOVED ADDITIONAL TISSUE FROM THE PATIENT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540488 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A LOCALIZER PROCEDURE, THE READER COULD NOT LOCATE THE MARKER. THE PHYSICIAN REPORTED THAT NOT ALL CANCER COULD BE REMOVED, AND THAT ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. HOLOGIC MADE SEVERAL ATTEMPTS TO OBTAIN THE INFORMATION WITHOUT RESPONSE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20633001 ↗
• InjuryFeb 2, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS ON THE TABLE UNDER ANESTHESIA, AND THE READER DISTANCE ON THE SCREEN WAS JUMPING AROUND FROM NEAR TO FAR UNCONTROLLABLY BOTH IN LOOP AND PENCIL PROBE SETTINGS. 4 SEPARATE PROBES WERE TRIED AND TWO READERS WERE TRIED UNSUCCESSFULLY. ULTRASOUND WAS BROUGHT IN TO FIND THE TAG AND WAS UNSUCCESSFUL AS WELL. TROUBLESHOOTING SUCH AS CHECKING THE PROBE CONNECTION WITH THE DRAPE, TURNING ON/OFF TO RECALIBRATE, AND REMOVING THE SYSTEM FROM RESTING ON METAL WAS ALL TESTED UNSUCCESSFULLY. AN INCISION WAS ALREADY MADE TO THE PATIENT WHEN THE ISSUE OCCURRED. THE PATIENT WILL BE RETURNING FOR A MASTECTOMY AT A LATER DATE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632874 ↗
• InjuryFeb 2, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS ON THE TABLE UNDER ANESTHESIA, AND THE READER DISTANCE ON THE SCREEN WAS JUMPING AROUND FROM NEAR TO FAR UNCONTROLLABLY BOTH IN LOOP AND PENCIL PROBE SETTINGS. 4 SEPARATE PROBES WERE TRIED AND TWO READERS WERE TRIED UNSUCCESSFULLY. ULTRASOUND WAS BROUGHT IN TO FIND THE TAG AND WAS UNSUCCESSFUL AS WELL. TROUBLESHOOTING SUCH AS CHECKING THE PROBE CONNECTION WITH THE DRAPE, TURNING ON/OFF TO RECALIBRATE, AND REMOVING THE SYSTEM FROM RESTING ON METAL WAS ALL TESTED UNSUCCESSFULLY. AN INCISION WAS ALREADY MADE TO THE PATIENT WHEN THE ISSUE OCCURRED. THE PATIENT WILL BE RETURNING FOR A MASTECTOMY AT A LATER DATE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632406 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A LUMPECTOMY PROCEDURE WAS PERFORMED AND THE LOCALIZER READER WAS NOT FUNCTIONING PROPERLY. THE PENCIL PROBE FROM THE MOMENT IT WAS PLUGGED IN MADE ITS AUDIBLE NOISE AND THE NUMBERS ON THE SCREEN INDICATING A DISTANCE OF PROBE FROM RFID TAG STARTED TO FLAG ON THE SCREEN AND WERE ALL OVER THE BOARD (10MM, 49MM, 30MM, ETC.) EVEN THOUGH THE READER AND PROBE WERE MULTIPLE FEET FROM THE TAG INSIDE THE PATIENTS BREAST. THE PATIENT WAS LEFT UNDER GENERAL ANESTHESIA FOR PROLONGED PERIOD OF TIME COMPARED TO A TRADITIONAL WIRE REMOVAL DUE TO EQUIPMENT/READER MALFUNCTIONING AND TROUBLESHOOTING. SURGEON DID NEED TO TAKE LARGER MARGINS THAN NORMAL FOR THIS TECHNOLOGY DUE TO THE UNCERTAINTY OF MM DISTANCE PROBE TO RFID TAG INDICATED BY THE LOCALIZER READER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697253 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OCTOBER 6TH, 2022, A LUMPECTOMY PROCEDURE WAS PERFORMED AND THE LOCALIZER READER WAS NOT FUNCTIONING PROPERLY. THE PENCIL PROBE FROM THE MOMENT IT WAS PLUGGED IN MADE ITS AUDIBLE NOISE AND THE NUMBERS ON THE SCREEN INDICATING A DISTANCE OF PROBE FROM RFID TAG STARTED TO FLAG ON THE SCREEN AND WERE ALL OVER THE BOARD (10MM, 49MM, 30MM, ETC.) EVEN THOUGH THE READER AND PROBE WERE MULTIPLE FEET FROM THE TAG INSIDE THE PATIENTS BREAST. THE PATIENT WAS LEFT UNDER GENERAL ANESTHESIA FOR PROLONGED PERIOD OF TIME COMPARED TO A TRADITIONAL WIRE REMOVAL DUE TO EQUIPMENT/READER MALFUNCTIONING AND TROUBLESHOOTING. SURGEON DID NEED TO TAKE LARGER MARGINS THAN NORMAL FOR THIS TECHNOLOGY DUE TO THE UNCERTAINTY OF MM DISTANCE PROBE TO RFID TAG INDICATED BY THE LOCALIZER READER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697198 ↗
• InjurySep 28, 2022Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT DURING A LOCALIZER PROCEDURE ON (B)(6) 2022, THE PHYSICIAN COULD NOT LOCATE THE LOCALIZER TAG ON THE BREAST AND DECIDED TO RELY ON IMAGES AND SCARRING TISSUE TO GUIDE TO REMOVE THE MASS. THE SURGEON WAS UNSURE IF THE CORRECT MARGINS HAD BEEN REMOVED FROM THE PATIENT AND A POSSIBILITY OF HAVING TO RE-EXCISE THE PATIENT WAS AWAITING FROM PATHOLOGY RESULTS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499561 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST SURGERY ON JULY 15TH, THE PHYSICIAN USING THE LOCALIZER READER WAS NOT ABLE TO FIND THE LOCALIZER TAG DURING THE PROCEDURE. IT WAS REPORTED THAT THE TAG WAS PLACED ON A MARGIN FOR THE SAMPLE TO BE COLLECTED 1 WEEK BEFORE AND DURING THE PROCEDURE THE TAG WAS SEPARATED FROM THE SAMPLE AND FELL INTO THE BREAST CAVITY WHERE IT WAS SUCKED BY THE SUCTION LINE. THE PHYSICIAN DUE TO NOT BEING ABLE TO FIND THE TAG HAD TO PERFORM AN ADDITIONAL EXCISION ON THE SAMPLE AND THE PATIENT HAD TO BE KEPT OVER 1 ADDITIONAL HOUR UNDER GENERAL ANESTHESIA. THE TAG WAS WOUND AT THE END OF THE PROCEDURE IN ONE OF THE CANNISTERS WHERE THE SUCTION LINE ENDS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315848 ↗