MR GHIATAS Beaded Breast Localization Wire — Class II medical device recall Z-1900-2017
Terminated recall by Bard Peripheral Vascular Inc, reported 2017-05-10, distributed nationwide. It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR co
| Recall number | Z-1900-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2017-03-28 |
| Classified | 2017-05-01 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2017-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CA, CN, TW |
| Quantity | 570 units |
Product
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. .
Reason for recall
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1900-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.