Z-0830-2019 Class II Terminated
FDA device recall Z-0830-2019 was initiated by AtriCure, Inc. on January 22, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 12, 2020). Affected quantity: 6176 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- January 22, 2019
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6176 units
Product Description
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Reason for Recall
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.
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
Code Information
UDI - none Lot Numbers - All lots within expiry