FDAFDA · Food and drugs·Recall number Z-1017-2013
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Published April 3, 2013 · Recall initiated: March 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Distributor
- Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
- Lot
- Lot number GFWA0387
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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