Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 10, 2017
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 m
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Peripheral Vascular Inc recalled MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage… - a moderate-severity action.
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage… was recalled by Bard Peripheral Vascular Inc in May 10, 2017. Reason: It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR c…. Check the official notice for the remedy. Verify recall #Z-1900-2017 with the FDA Devices before acting.
The recall
Bard Peripheral Vascular Inc issued this moderate-severity FDA Devices recall-It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR c….
- Moderate
- severity level
- 570 units
- affected scope
- Class II
- classification
- May 10, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1900-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1900-2017) was formally reported on May 10, 2017, with the manufacturer initiating the action on March 28, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Bard Peripheral Vascular Inc is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 570 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
570 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1900-2017 |
| Date reported | May 10, 2017 |
| Date initiated | March 28, 2017 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Firm location | Tempe, AZ |
| Affected scope | 570 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1900-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. .. Recalled by Bard Peripheral Vascular Inc. Units affected: 570 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Moderate. Recall number: Z-1900-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1900-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 10, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.