AtriCure Isolator Synergy Clamp and Guide System OLH (REF A001143SB)Recalls & reported problems
Atricure, Inc. · Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide · 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 10840143905193), received between Mar 27, 2025 and Mar 27, 2025 — 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
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE WITH CONCOMITANT CARDIAC ABLATION USING AN OLH DEVICE. WHILE POSITIONING THE OLH CLAMP, THE PHYSICIAN IDENTIFIED AN INJURY, WHICH WAS REPAIRED WITH SUTURE. THE PRIMARY PROCEDURE WAS COMPLETED HOWEVER, THE CONCOMITANT PROCEDURE WAS ABORTED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.
Patient problems: Perforation
MAUDE report 21711760 ↗
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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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