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FDAJanuary 22, 2019device

COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

atricure

UPCs

00818354012828

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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