Isolator Surgical Ablation System MCR1Recalls & reported problems
Atricure, Inc. · Coolrail Linear Pen, 30 mm linear electrode · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818354010893), received between Dec 3, 2021 and Dec 3, 2021 — classified as 1 death.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fistula1
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021 A MALE PATIENT RECEIVED AN OPEN, CONCOMITANT ATRIAL VALVE REPLACEMENT WITH AN ABLATION FOR THE LEFT ATRIAL BOX LESION SET. THE CASE COMPLETED WITH NO PROCEDURAL OR DEVICE COMPLICATIONS. 2 WEEKS POST-OP, THE PATIENT WAS STILL HEALING WELL WITH NO COMPLICATIONS. APPROXIMATELY 4 WEEKS POST-OP ON (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER AN EPISODE OF DIZZINESS AND UNCONSCIOUSNESS. HE WAS TRANSFERRED TO ANOTHER FACILITY WHERE THE PATIENT ULTIMATELY EXPIRED. AUTOPSY REVEALED AN ATRIO-ESOPHAGEAL FISTULA IN THE REGION OF THE LEFT ATRIAL ROOF LESION. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.
Patient problems: Fistula; Sepsis
MAUDE report 12923500 ↗
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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