FDA-Device2019-02-20Class II
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
AtriCure, Inc.
Hazard
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
Sold states
AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia
Affected count
175 units
Manufactured in
7555 Innovation Way, N/A, Mason, OH, United States
Products
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2019Don't want to check this manually?
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