GHIATASRecalls & reported problems across all models

We found 8 models of GHIATAS by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2016 and Jul 31, 2026 — classified as 8 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GHIATAS problems

GHIATAS models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GHIATAS® 47920

  GUIDE, NEEDLE, SURGICAL
  20 reports
• GHIATAS® 47720

  GUIDE, NEEDLE, SURGICAL
  7 reports
• GHIATAS® 477201

  GUIDE, NEEDLE, SURGICAL
  7 reports
• GHIATAS® 475201

  GUIDE, NEEDLE, SURGICAL
  6 reports
• GHIATAS® 479201

  GUIDE, NEEDLE, SURGICAL
  5 reports
• GHIATAS® 49520

  GUIDE, NEEDLE, SURGICAL
  1 report
• GHIATAS® 49720

  GUIDE, NEEDLE, SURGICAL
  1 report
• GHIATAS® 49920

  GUIDE, NEEDLE, SURGICAL
  1 report

Recent GHIATAS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096860 ↗
• MalfunctionJul 29, 2026Device Contamination with Chemical or Other Material

  On (b)(6) 2026, a patient was scheduled to undergo a localization wire placement procedure using a Ghiatas Breast Localization Wire. Prior to the procedure, foreign material was observed on the needle. The procedure was subsequently completed using an alternative device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065835 ↗
• 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 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT PREPARED FOR A BREAST LOCAIZATION WIRE PLACEMENT PROCEDURE USING GHIATAS. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE LEAD COVER OF THE WIRE WAS DETACHED FROM THE WIRE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276634 ↗
• MalfunctionApr 22, 2025Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST LOCALIZATION WIRE PLACEMENT USING GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE OUTER SHEATH WAS BENT HALFWAY THROUGH AND DIFFICULT TO REMOVE IT FROM THE PATIENT WHILE ENSURING THE HOOKWIRE STAYED IN PLACE WITHIN THE BREAST TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880571 ↗
• 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 ↗
• InjuryFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST A MAMMOGRAPHY GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE BREADED OF THE LOCALIZATION WIRE FALL OF AND REMAINED IN THE BREAST TISSUE. THE BROKEN PART STILL IN PATIENT. PATIENT WILL UNDERGO SURGICAL INTERVENTION FOR REMOVAL THE BROKEN PART. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21399699 ↗

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