GHIATAS® 477201Recalls & reported problems
Bard Peripheral Vascular, Inc. · MR GHIATAS® Beaded Breast Localization Wire, 20g x 7cm needle · Class 1 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741079924), received between Dec 1, 2016 and Oct 23, 2020 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Signal Artifact/Noise” (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
Device problems
- Signal Artifact/Noise6
- Device Markings/Labelling Problem3
- Break1
- Image Display Error/Artifact1
Patient problems
- No Consequences Or Impact To Patient6
- Injury1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2020Break; Image Display Error/Artifact; Break; Image Display Error/Artifact
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 477201 BIOPSY INSTRUMENT EXPERIENCED BREAK AND IMAGE DISPLAY ERROR/ARTIFACT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10731360 ↗MalfunctionOct 16, 2019Signal Artifact/Noise; Device Markings/Labelling Problem; Signal Artifact/Noise; Device Markings/Labelling Problem
THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 477201 LOCALIZATION WIRE ALLEGEDLY PRODUCED ARTIFACTS DURING IMAGING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT WAS REPORTED AS 86 YEARS OLD, WEIGHING 114 POUNDS, THE GENDER OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9200122 ↗MalfunctionOct 16, 2019Signal Artifact/Noise; Signal Artifact/Noise
THIS REPORT SUMMARIZES SIX MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 477201 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED A SIGNAL ARTIFACT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE SIX MALFUNCTIONS, ONE INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT AND FIVE DID NOT INVOLVE A PATIENT. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9198865 ↗InjuryAug 27, 2019Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT POST PLACEMENT OF A LOCALIZATION WIRE, AN ARTIFACT ALLEGEDLY WAS FOUND ON MRI IMAGING. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Injury
MAUDE report 8937675 ↗MalfunctionMay 30, 2018Signal Artifact/Noise; Device Markings/Labelling Problem; Signal Artifact/Noise; Device Markings/Labelling Problem
IT WAS REPORTED THAT POST PLACEMENT OF A LOCALIZATION WIRE, AN ARTIFACT ALLEGEDLY WAS FOUND ON MR IMAGING. THE LOCALIZATION WIRE REPORTEDLY WAS NON-MR AND INCORRECTLY PACKAGED WITH MR LABELING. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME WIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7554246 ↗MalfunctionMay 26, 2017Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT ALLEGEDLY DURING A BREAST LOCALIZATION WIRE PLACEMENT INTO NORMAL TISSUE DENSITY, THE HEALTH CARE PROVIDER WAS UNABLE TO CONFIRM THE PLACEMENT OF THE WIRE BECAUSE OF THE ALLEGED BLOOMING ARTIFACT FROM THE WIRE. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6596021 ↗MalfunctionDec 1, 2016Signal Artifact/Noise; Device Markings/Labelling Problem; Signal Artifact/Noise; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING A BREAST LOCALIZATION WIRE PLACEMENT, THE DEVICE ALLEGEDLY CREATED AN ARTIFACT UNDER MRI IMAGING. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6140118 ↗
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
- 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.