AtriCure, Inc. recalls COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
See all recalls from AtriCure, Inc. →Recalled Product
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Hazard / Issue
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.
Issued by
FDA
Affected States: 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
Lot/Code Info: UDI - none Lot Numbers - All lots within expiry
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for COBRA FUSION 150 Ablation →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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