GHIATAS® 475201Recalls & reported problems
Bard Peripheral Vascular, Inc. · MR GHIATAS® Beaded Breast Localization Wire, 20g x 5cm needle · Class 1 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741079917), received between Jul 30, 2019 and Apr 13, 2021 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (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.
Most reported problems
Device problems
- Image Display Error/Artifact3
- Signal Artifact/Noise3
- Break1
Patient problems
- No Consequences Or Impact To Patient4
- Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2021Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT POST PLACEMENT OF A BREAST LOCALIZATION WIRE, AN ARTIFACT WAS ALLEGEDLY FOUND ON MRI IMAGES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11655902 ↗MalfunctionOct 23, 2020Image Display Error/Artifact; Image Display Error/Artifact
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 475201 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED ARTIFACT FROM THE BREAST MARKER WAS LARGER IN SIZE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10731359 ↗MalfunctionOct 23, 2020Break; Image Display Error/Artifact; Break; Image Display Error/Artifact
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL 475201 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION WAS INVOLVED PATIENT WITH NO REPORTED CONSEQUENCES. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10729494 ↗MalfunctionApr 9, 2020Signal Artifact/Noise; Signal Artifact/Noise
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 475201 BIOPSY INSTRUMENT EXPERIENCED A SIGNAL ARTIFACT. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE 46 YEAR OLD FEMALE PATIENT WEIGHED 113 LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9944298 ↗MalfunctionOct 16, 2019Signal Artifact/Noise; Signal Artifact/Noise
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 475201 BIOPSY INSTRUMENT ALLEGEDLY HAD SIGNAL ARTIFACT ON MRI IMAGING. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9200115 ↗InjuryJul 30, 2019Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT POST PLACEMENT OF A LOCALIZATION WIRE, AN ARTIFACT ALLEGEDLY WAS FOUND ON MRI IMAGING. REPORTEDLY, THE PATIENT WENT TO THE OR TO REMOVE THE LOCALIZATION WIRE. IT WAS FURTHER REPORTED THAT THERE WAS NO ANY ADDITIONAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Injury
MAUDE report 8842928 ↗
Other GUIDE, NEEDLE, SURGICAL devices
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- 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® 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.