Isolator Surgical Ablation System EMR2 (REF A000452)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840143902161), received between Oct 13, 2023 and Jul 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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.

• InjuryJul 28, 2025Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT CARDIAC TISSUE ABLATION FOR TREATMENT OF IST USING EMR2 CLAMP AS PART OF THE HEAL-IST IDE TRIAL (G210309). A PICC LINE HAD BEEN PREVIOUSLY PLACED FOR AN UNDISCLOSED CONDITION. THE PHYSICIAN ABLATED ACROSS THE SVC AND DID NOT WITHDRAW THE PICC LINE PRIOR TO THE ABLATION, DESPITE ADVISEMENT FROM ATRICURE PERSONNEL IN ATTENDANCE. A CHEST X-RAY DONE ON (B)(6) 2025 SHOWED A POTENTIAL FOREIGN BODY IN PATIENT'S LEFT PULMONARY ARTERY. IT WAS DETERMINED THAT THE FOREIGN BODY WAS THE TIP OF A PICC LINE WHICH WAS DAMAGED DURING THE EPICARDIAL ABLATION. THE PATIENT WAS ADMITTED ON (B)(6) 2025 FOR REMOVAL OF THE ¿DISTAL FRAGMENT OF THE PICC LINE¿ BY INTERVENTIONAL RADIOLOGY. THERE WAS NO PRODUCT MALFUNCTION, AND THE EVENT WAS THE RESULT OF A USE ERROR.

  Patient problems: Foreign Body In Patient

  MAUDE report 22628937 ↗
• InjuryJul 16, 2025Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT ROBOTIC VATS CARDIAC TISSUE ABLATION FOR TREATMENT OF IST USING EMR2 CLAMP. A PORT-A-CATH HAD BEEN PLACED ONE DAY PRIOR FOR AN UNDISCLOSED CONDITION. THE PHYSICIAN ABLATED ACROSS THE SVC AND DID NOT WITHDRAW THE PORT-A-CATH PRIOR TO THE ABLATION, DESPITE ADVISEMENT FROM ATRICURE PERSONNEL IN ATTENDANCE. POST-OPERATIVELY, A CHEST X-RAY SHOWED THAT A 2-3 CM SEGMENT OF PORT-A-CATH HAD BEEN SHEARED OFF AND WAS LODGED IN LOWER LOBE OF PATIENT¿S LEFT LUNG. THE SEGMENT WAS SUCCESSFULLY RETRIEVED IN A SUBSEQUENT PROCEDURE BY INTERVENTIONAL RADIOLOGY. THERE WAS NO PRODUCT MALFUNCTION, AND THE EVENT WAS THE RESULT OF A USE ERROR.

  Patient problems: Foreign Body In Patient

  MAUDE report 22523718 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PATIENT UNDERWENT A SINUS NODE MODIFICATION PROCEDURE. AFTER THE EPICARDIAL PORTION OF THE PROCEDURE, THE PATIENT'S HEART RHYTHM CONVERTED FROM SINUS TO JUNCTIONAL. BOTH THE EPICARDIAL AND ENDOCARDIAL PORTION OF THE PROCEDURE WERE COMPLETED, AS PLANNED. POST-OPERATIVELY, THE PATIENT REMAINED IN JUNCTIONAL RHYTHM AND WAS DISCHARGED FROM HOSPITAL WITHOUT INTERVENTION ON THE THIRD POSTOPERATIVE DAY. JUNCTIONAL RHYTHM PERSISTED ALONG WITH SYMPTOMS RELATED TO CHRONOTROPIC INCOMPETENCE. THE PATIENT WAS ADMITTED ON (B)(6) 2023 FOR IMPLANTATION OF DUAL CHAMBER PACEMAKER. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Arrhythmia

  MAUDE report 17933977 ↗