Synergy™ Ablation System OSL2Recalls & reported problems
Atricure, Inc. · Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143902192), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
AN OSL2 DEVICE HAD A MISMATCHED EXPIRATION DATE BETWEEN THE UNIT OF USE AND THE UNIT OF SALE. THE EXPIRATION DATE ON THE UNIT OF SALE WAS CORRECT BUT THE EXPIRATION DATE ON THE UNIT OF USE WAS INCORRECT. THE DEVICE WAS NOT USED AND WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED HARM TO PATIENT OR DELAY OR PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19205759 ↗
Other Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation devices
- Synergy™ Ablation System OLL2Atricure, Inc. · Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation1 death7 reports
- Cannula with Guide CSK-6131Atricure, Inc. · Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation3 reports
- EPi-Sense Guided Coagulation System with VisiTrax CDK-1413Atricure, Inc. · Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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