Fusion Ablation SystemRecalls & reported problems across all models

We found 2 models of Fusion Ablation System by Atricure, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Fusion Ablation System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 22, 2019Terminated

   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.

   Z-0831-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. Jan 22, 2019Terminated

   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.

   Z-0829-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Fusion Ablation System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fusion Ablation System 001-700-002

  Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
  1 recall0 reports
• Fusion Ablation System 001-700-001S

  Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
  1 recall0 reports