GHIATAS® 49920Recalls & reported problems
Bard Peripheral Vascular, Inc. · GHIATAS® Beaded Breast Localization Wire with Stiffened Section, 20g x 9cm needle · Class 1 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741079894), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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
- GHIATAS® 479201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
- DuaLok™ LW0077Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.