GHIATAS® 47920Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741079832), received between May 8, 2018 and Feb 9, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT PREPPED FOR A BIOPSY PROCEDURE USING THE GHIATAS LOC WIRE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BARCODE WAS NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290207 ↗
• MalfunctionFeb 9, 2026Device Markings/Labelling Problem

  A PATIENT PREPPED FOR A BIOPSY PROCEDURE USING THE GHIATAS LOC WIRE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BARCODE WAS NOT READABLE BY RADIO FREQUENCY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289959 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Remove; Material Twisted/Bent; Difficult to Insert; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST MARKER PLACEMENT THROUGH THE GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE NEEDLE WAS BENT AT THE TIP OF THE BEVEL. DUE TO THE BENT TIP, INSERTION INTO THE PATIENT'S SKIN WAS MORE DIFFICULT AND CAUSED THE SKIN TO TEAR WHEN IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740779 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Remove; Material Twisted/Bent; Difficult to Insert; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST MARKER PLACEMENT THROUGH THE GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE NEEDLE WAS BENT AT THE TIP OF THE BEVEL. DUE TO THE BENT TIP, INSERTION INTO THE PATIENT'S SKIN WAS MORE DIFFICULT AND CAUSED THE SKIN TO TEAR WHEN IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740711 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Remove; Material Twisted/Bent; Difficult to Insert; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST MARKER PLACEMENT THROUGH THE GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE NEEDLE WAS BENT AT THE TIP OF THE BEVEL. DUE TO THE BENT TIP, INSERTION INTO THE PATIENT'S SKIN WAS MORE DIFFICULT AND CAUSED THE SKIN TO TEAR WHEN IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740667 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Remove; Material Twisted/Bent; Difficult to Insert; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST MARKER PLACEMENT THROUGH THE GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE NEEDLE WAS BENT AT THE TIP OF THE BEVEL. DUE TO THE BENT TIP, INSERTION INTO THE PATIENT'S SKIN WAS MORE DIFFICULT AND CAUSED THE SKIN TO TEAR WHEN IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739902 ↗
• MalfunctionMar 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PACKAGING ALLEGEDLY HAD A HAIR. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603169 ↗
• MalfunctionMar 11, 2025Image Display Error/Artifact; Improper or Incorrect Procedure or Method; Image Display Error/Artifact; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT, THERE WAS NO SPECIFICATION ON THE PACKAGING REFERRING TO MRI. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574472 ↗
• MalfunctionMar 11, 2025Image Display Error/Artifact; Improper or Incorrect Procedure or Method; Image Display Error/Artifact; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT, THERE WAS NO SPECIFICATION ON THE PACKAGING REFERRING TO MRI. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572346 ↗
• MalfunctionMar 11, 2025Image Display Error/Artifact; Improper or Incorrect Procedure or Method; Image Display Error/Artifact; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT, THERE WAS NO SPECIFICATION ON THE PACKAGING REFERRING TO MRI. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572047 ↗
• InjuryMar 23, 2024Break; Break

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE BEADED BREAST LOCALIZATION WIRE, THE SURGEON PULLED THE WIRE OUT AND THE HOOK ALLEGEDLY BROKE OFF AND REMAINED IN THE PATIENT. REPORTEDLY, THE HOOK WAS NOT RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18966241 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE BREAST POSITIONING NEEDLE MARKER BEADS ALLEGEDLY FOUND TO BE FALLEN OFF. REPORTEDLY, ALL THE THREE MARKER BEADS THAT THE NEEDLE CONTAINED WERE COMPLETELY REMOVED, AND THERE WAS NO RESIDUE IN THE PATIENT'S WOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928240 ↗
• MalfunctionFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST MARKER PLACEMENT PROCEDURE, THE NEEDLE MARKER BEADS ALLEGEDLY FELL OFF AND FELL INTO THE PATIENT'S BODY. REPORTEDLY, THE MARKER BEADS WERE COMPLETELY REMOVED, AND THERE WAS NO RESIDUE LEFT IN THE PATIENT'S WOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787086 ↗
• MalfunctionOct 27, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A MAMMOGRAPHY GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679333 ↗
• MalfunctionMar 16, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13784259 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT DURING THE BREAST LOCALIZATION WIRE PLACEMENT, THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293650 ↗
• MalfunctionApr 21, 2021Failure to Advance; Device Contamination with Chemical or Other Material; Failure to Advance; Device Contamination with Chemical or Other Material

  A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 47920 BREAST LOCALIZATION WIRE ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701088 ↗
• MalfunctionApr 4, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 47920 LOCALIZATION WIRE ALLEGEDLY HAD FOREIGN MATERIAL ON THE NEEDLE, UPON REMOVAL FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT FOR THIS ONE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8485173 ↗
• MalfunctionOct 29, 2018Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE DEVICE ALLEGEDLY WAS NOT CLEAN. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8016792 ↗
• MalfunctionMay 8, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE PRIOR TO A BREAST BIOPSY, THE NEEDLE ALLEGEDLY WAS THE INCORRECT LENGTH. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7496009 ↗