Reported Apr 3, 2013 · Terminated
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement…
Medtronic Inc. Cardiac Rhythm Disease Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. Cardiac Rhythm Disease Management · 8200 Coral Sea St NE · Saint Paul, MN · 55112-4391
Is this the product you have?
- Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
- Lot codes and dates
- Lot number GFWA0387
- Amount recalled
- 225 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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