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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Recall Number Z-1017-2013
Classification Class II
Code Info Lot number GFWA0387
Product Distributed Qty 225 units
Reason For Recall Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.

Event Detail

Event Id 64620
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Inc. Cardiac Rhythm Disease Management
City Saint Paul
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.