FDA-Device2013-04-03Class II
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
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.
Sold states
Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
Affected count
225 units
Manufactured in
8200 Coral Sea St NE, Saint Paul, MN, United States
Products
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2013Don't want to check this manually?
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