Fusion Ablation System 001-700-002Recalls & reported problems
Atricure, Inc. · Fusion 50 Ablation System · Class 2
All models of Fusion Ablation System (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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 ↗
Other Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue devices
- Cardioblate® CryoFlex® 60SF3Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall7 deaths41 reports
- Cardioblate® CryoFlex® 60SF2Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall13 reports
- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death11 reports
- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death6 reports
- CARDIOBLATE® GEMINI® 49260Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 report
- Cardioblate® CryoFlex® 60SF7Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 report
- Cardioblate® CryoFlex® 60CM1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall0 reports
- Fusion Ablation System 001-700-001SAtricure, Inc. · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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