FDA-Device2016-11-16Class I
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
SentreHeart Inc
Hazard
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
Sold states
Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
Affected count
132 worldwide distribution (98) of those units in US
Manufactured in
300 Saginaw Dr, Redwood City, CA, United States
Products
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0328-2017Don't want to check this manually?
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