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Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placemen
Recalled April 3, 2013 · FDA recall Z-1017-2013 · Medtronic Inc. Cardiac Rhythm Disease Management
Hazard
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. · FDA Class II
Units
225 units
Sold at
Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
Description
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.
Product
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Manufacturer(s)
Medtronic Inc. Cardiac Rhythm Disease Management
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →