Isolator Surgical Ablation System EML2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840143902222), received between Jan 2, 2025 and Jan 29, 2025 — classified as 3 injuries.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT BILATERAL VIDEO-ASSISTED THORACOSCOPIC APPROACH SURGERY (VATS) WITH CONCOMITANT PULMONARY VEIN ISOLATION USING AN EML2 CLAMP. FOLLOWING THE RELEASE OF THE CLAMP AFTER THE THIRD LESION WAS CREATED, A 2CM HOLE WAS DISCOVERED IN THE LEFT ATRIUM WHERE THE CLAMP HAD BEEN PLACED. TO PREVENT BLOOD LOSS, THE CLAMP WAS REAPPLIED. THE PATIENT WAS THEN PLACED ON CARDIOPULMONARY BYPASS, AND A SMALL THORACOTOMY INCISION WAS MADE TO REPAIR THE HOLE. THE REMAINDER OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 21265622 ↗
• InjuryJan 14, 2025

  ATRICURE RF (RADIOFREQUENCY) CLAMP WAS PLACED ON LEFT PULMONARY VEIN. WHEN REMOVING CLAMP, THERE WAS DARK RED BLOOD. CLAMP WAS IMMEDIATELY PLACED BACK ON FOR CONTROL OF HEMORRHAGE. PATIENT WAS EMERGENTLY CANNULATED AND PLACED ON CARDIOPULMONARY BYPASS FOR REPAIR OF PULMONARY VEIN. SITE OF BLEEDING WAS REPAIRED WITH INCORPOREAL STITCHES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 21147638 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A TOTALLY THORACOSCOPIC MAZE PROCEDURE. DURING INSERTION OF THE EML2 CLAMP AROUND THE LEFT PULMONARY VEINS (LPV), THE LPV WAS TORN, AND BLEEDING OCCURRED. A MIDLINE INCISION WAS PERFORMED, AND THE INJURY WAS REPAIRED. THE PATIENT IS RECOVERING. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 21061511 ↗