Reported Feb 20, 2019 · Terminated
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
AtriCure, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AtriCure, Inc. · 7555 Innovation Way · Mason, OH · 45040-9695
Is this the product you have?
COBRA FUSION 150 Ablation SystemCatalog # (REF) 700-001
- Lot codes and dates
- UDI - none Lot Numbers - All lots within expiry
- Amount recalled
- 6176 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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