COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
This recall has been terminated (originally issued January 22, 2019).
- Company
- Atricure, Inc.
- Recall Initiated
- January 22, 2019
- Terminated
- May 12, 2020
- Recall Number
- Z-0830-2019
- Quantity
- 6176 units
- Firm Location
- Mason, OH
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
UDI - none Lot Numbers - All lots within expiry
Root Cause
Unknown/Undetermined by firm
Action Taken
On January 22, 2019, AtriCure distributed URGENT Advisory Notices to customers via certified mail. AtriCure is providing modifications to the existing Cobra Fusion Instruction for Use (IFU), to address contributing TE Factors associated with stand-alone off-pump procedures. These are in addition to the warnings and precautions that are present within the current IFU. Modifications to Warnings: When utilizing the Cobra Fusion device in a stand-alone off-pump (without CPB) procedure, the following should be considered: - Physicians should consider a comprehensive anti-coagulation protocol including pre-operative, intra-operative and post-operative anti-coagulation management to prevent potential thromboemboli. Modifications to Precautions: - Post-operative anti-coagulation therapy for protection against thromboemboli is inclusive of the bridging period between the end of the procedure and until effective therapeutic levels of Oral Anticoagulation (OAC) are achieved. Customers Should Take the following Action: - Read and follow the revised Instructions for Use IFU enclosed with the notification letter when using the Cobra Fusion. - Report any post ablation thromboembolic event with the Cobra Fusion, to AtriCure by phone at 1-866-349-2342 (select option 6) or e-mail to pcomplaints@atricure.com. - Return the completed Acknowledgement Form. Contact Information: If you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-644-4245) from 9-6pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for review promptly. **Press Release will be issue depended on CDRH comment/review**