Isolator Surgical Ablation System EMR2 (REF A000452)Recalls & reported problems
Atricure, Inc. · Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818354010756), received between May 24, 2024 and May 24, 2024 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pneumonia1
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT ABLATION PROCEDURE FOR INAPPROPRIATE SINUS TACHYCARDIA (IST) AS PART OF IDE # (B)(4). THE PATIENT WAS HEPARINIZED DURING THE PROCEDURE, WHICH WAS SUCCESSFULLY COMPLETED, AFTER WHICH THE PATIENT WAS DISCHARGED TO HOME. THE PATIENT HAD MEDICAL HISTORY OF PRIOR VENOUS THROMBOEMBOLISM AND TYPE II DIABETES MELLITUS. ON POD 6, THE PATIENT PRESENTED TO THE ED WITH RIGHT-SIDED CHEST PAIN AND DYSPNEA, AND WAS DIAGNOSED WITH PNEUMONIA FOR WHICH ANTIBIOTICS WERE PRESCRIBED. ON POD 12, THE PATIENT PRESENTED TO THE ED WITH CHEST PAIN AND SHORTNESS OF BREATH. A CT-ANGIOGRAM CONFIRMED PULMONARY EMBOLI WITHIN BILATERAL LOWER LOBAR PULMONARY ARTERIES. THE PATIENT WAS MEDICALLY MANAGED WITH HEPARIN DRIP, THEN TRANSITIONED TO ELIQUIS. BOTH THE ADVERSE EVENTS OF PNEUMONIA AND PULMONARY EMBOLISM WERE ASSESSED BY CLINICAL TRIAL INVESTIGATOR WITH "UNKNOWN" RELATEDNESS TO INDEX PROCEDURE, AND NOT RELATED TO ATRICURE INVESTIGATIONAL DEVICE. WHILE IT IS NOT POSSIBLE TO IDENTIFY CAUSE OR CONTRIBUTION OF THE EMR2 DEVICE, THIS EVENT IS BEING REPORTED PER PART 803. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.
Patient problems: Pneumonia; Pulmonary Embolism
MAUDE report 19397192 ↗
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 001-700-002Atricure, 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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