Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1017-2013

Z-1017-2013 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
April 3, 2013
Initiation Date
March 13, 2013
Termination Date
November 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
225 units

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.

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.

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.

Code Information

Lot number GFWA0387

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