The Recall Desk
HighFDA (Devices)·Z-1900-2017·Announced 2017-05-10

Bard MR GHIATAS Beaded Breast Localization Wire Recalled for Compatibility Risk

Bard Peripheral Vascular Inc. is recalling 570 units of MR GHIATAS Beaded Breast Localization Wire because they may be non-MR compatible instead of MR compatible.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may be non-MR compatible, posing a risk of harm during MRI procedures, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Bard Peripheral Vascular Inc. is recalling 570 units of the MR GHIATAS Beaded Breast Localization Wire, Product Codes 477201 and 479201. The recall was initiated because the devices may be at risk of containing a non-MR compatible wire instead of the intended MR compatible version. The product is intended for use during breast lesion surgery as a guide for the surgeon to follow in the excision of the lesion.

The affected units were distributed worldwide, including nationwide in the United States in the states of TX, FL, MO, NJ, WI, AL, CA, OK, AZ, NC, GA, ID, WA, NY, and NM, as well as in Brazil, Canada, China, Taiwan, and Belgium. The specific lot codes associated with the recall are REYB1777, REZI0726, REZI0988, REZK0741, REZL0066, and REAN0884.

Healthcare providers and facilities should check their inventory for these specific product codes and lot numbers. If the devices are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have had these devices implanted should contact their healthcare provider for evaluation.

The recalled product

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 surg
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
570

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Related recalls

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