Device product
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Z-0829-2019
Product summary
- Firm
- AtriCure, Inc.
- Event
- Event 81932
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1288 units
- Official record key
device-enforcement:Z-0829-2019
Official wording
Reason: 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.
Code information: UDI - 00818354012811 Lot Numbers - All lots within expiry
Distribution pattern: 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
Derived failure modes
-
Unknown
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.