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GHIATAS® 49520Recalls & reported problems

Bard Peripheral Vascular, Inc. · GHIATAS® Beaded Breast Localization Wire with Stiffened Section, 20g x 5cm 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 00801741079870), received between Jan 30, 2017 and Jan 30, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 30, 2017Break; Break

    IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST TISSUE LOCALIZATION PROCEDURE, THE NEEDLE HUB ALLEGEDLY BROKE WHEN THE HEALTH CARE PROVIDER WAS INSERTING THE NEEDLE INTO THE TARGET TISSUE. IT WAS FURTHER REPORTED THAT THE INTRODUCER WAS ALLEGEDLY INTACT BEFORE INSERTION AND THAT NOTHING HAD BEEN ATTACHED TO THE NEEDLE HUB. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6288193 ↗

Other GUIDE, NEEDLE, SURGICAL devices

All GUIDE, NEEDLE, SURGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.