Fusion Ablation System recallZ-0829-2019 · AtriCure, Inc. · initiated Jan 22, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AtriCure, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
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 [email protected]. - 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**
Recall details
- Recall number
- Z-0829-2019
- Status
- Terminated
- Initiated by the company
- Jan 22, 2019
- Recalling firm
- AtriCure, Inc.
- Quantity
- 1288 units
- Product code
- OCL
- FDA submissions
- K113475
- 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
Product description
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Code information (models, lots, serial numbers)
UDI - 00818354012811 Lot Numbers - All lots within expiry
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fusion Ablation System 001-700-002Atricure, Inc. · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 81932).
- Z-0831-2019 · TerminatedCOBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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