GHIATAS® 47720Recalls & reported problems
Bard Peripheral Vascular, Inc. · GHIATAS® Beaded Breast Localization Wire, 20g x 7cm needle · Class 1 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741079818), received between Oct 16, 2019 and Jul 31, 2026 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material3
- Detachment of Device or Device Component2
- Break1
- Device Markings/Labelling Problem1
- Nonstandard Device1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 7 most recent of 7 reports, 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 ↗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 ↗InjuryAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT SOMETIME POST A BREAST BIOPSY PROCEDURE, THE MAMMOGRAPHY IMAGE ALLEGEDLY CONFIRMED THAT THE BEADED WIRE ALLEGEDLY FELL OFF AND REMAINED IN THE BREAST TISSUE. REPORTEDLY, A SURGERY WILL BE PERFORMED TO REMOVED THE SEPARATED WIRE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 20018524 ↗InjuryJul 22, 2021Break; Break
IT WAS REPORTED THAT POST BIOPSY PROCEDURE, THE LOCALIZATION WIRE ALLEGEDLY BROKE AND THE WIRE REMAINS IN THE PATIENT. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12210390 ↗MalfunctionJan 9, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 47720 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DEVICE MARKINGS ISSUE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS HAD NO REPORTED PATIENT INVOLVEMENT. THE PATIENTS¿ AGE, WEIGHT, AND SEX WERE NOT PROVIDED FOR EITHER MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9572361 ↗MalfunctionOct 16, 2019Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 47720 BIOPSY INSTRUMENT ALLEGEDLY WAS FOUND TO BE NONSTANDARD DEVICE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT AGE, GENDER AND WEIGHT WAS NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9198940 ↗
Other GUIDE, NEEDLE, SURGICAL devices
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- DuaLok™ LW0107Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL11 reports
- GHIATAS® 477201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 reports
- PERL Localization Device R2020Focal Therapeutics, Inc. · Guide, Needle, Surgical7 reports
- GHIATAS® 475201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL6 reports
- GHIATAS® 479201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
- DuaLok™ LW0077Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
- DuaLok™ LW0057Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.