Z-0829-2019 Class II Terminated
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
- 1288 units
Product Description
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
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 - 00818354012811 Lot Numbers - All lots within expiry