GHIATAS® 479201Recalls & reported problems
Bard Peripheral Vascular, Inc. · MR GHIATAS® Beaded Breast Localization Wire, 20g x 9cm needle · Class 1 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741079931), received between Nov 8, 2016 and Apr 22, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Signal Artifact/Noise” (4 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
- Signal Artifact/Noise4
- Difficult to Advance1
- Difficult to Remove1
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJan 20, 2020Signal Artifact/Noise; Signal Artifact/Noise
THIS REPORT SUMMARIZES THE ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 479201 BREAST LOCALIZATION WIRE ALLEGEDLY EXPERIENCED SIGNAL ARTIFACT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE SIGNAL ARTIFACT, ONE INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9607032 ↗MalfunctionNov 9, 2016Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT AFTER A BREAST WIRE LOCALIZATION PROCEDURE ON A PHANTOM PATIENT AND TISSUE, THE WIRE ALLEGEDLY PRODUCED AN ARTIFACT THAT WAS VISIBLE UNDER MR IMAGING AND AFFECTED THE READING OF THE IMAGE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6089558 ↗InjuryNov 8, 2016Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT DURING A MRI BREAST EXCISION, THE LOCALIZATION WIRE WAS ALLEGEDLY DISPLAYING AN ARTIFACT ON THE MRI. REPORTEDLY, THE USER PROCEEDED WITH THE WIRE IN PLACE AND THE AMOUNT OF EXCISED TISSUE AREA WAS ENLARGED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6087869 ↗InjuryNov 8, 2016Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT DURING A MRI BREAST EXCISION, THE LOCALIZATION WIRE WAS ALLEGEDLY DISPLAYING AN ARTIFACT ON THE MRI. REPORTEDLY, THE USER PROCEEDED WITH THE WIRE IN PLACE AND THE AMOUNT OF EXCISED TISSUE AREA WAS ENLARGED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6087812 ↗
Other GUIDE, NEEDLE, SURGICAL devices
- GHIATAS® 47920Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL20 reports
- DuaLok™ LW0107Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL11 reports
- GHIATAS® 47720Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 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
- DuaLok™ LW0077Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
- DuaLok™ LW0057Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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