AtriCure Isolator Synergy Clamp and Guide System OLH (REF A001143SB)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10840143905834), received between Jul 20, 2023 and Mar 12, 2026 — classified as 1 death, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT AORTIC VALVE REPAIR/REPLACEMENT (AVR) VIA MEDIAN STERNOTOMY WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION. DURING A FRAME SHIFT FOLLOWING THE INITIAL ABLATION, A HOLE WAS IDENTIFIED IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV). THE INJURY WAS SUCCESSFULLY REPAIRED WITH A PATCH AND SUTURE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 24586491 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) AND AORTIC VALVE REPAIR/REPLACEMENT (AVR) THROUGH A MEDIAN STERNOTOMY, ALONG WITH A POSTERIOR WALL ENCIRCLING ABLATION USING AN OLH. DURING THE MANEUVERING OF THE OLH CLAMP FROM THE PATIENT¿S RIGHT TO LEFT SIDE THROUGH THE SINUSES, A PERFORATION OCCURRED. THE INJURY WAS REPAIRED WITH SUTURES. THE PATIENT WAS THEN MOVED TO RECOVERY AND REPORTED TO BE DOING WELL. THE ABLATION PORTION OF THE PROCEDURE WAS ABORTED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 20353026 ↗
• DeathSep 23, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT AND AORTIC ROOT REPLACEMENT PROCEDURE, WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION USING AN OLH VIA MEDIAN STERNOTOMY. WHEN PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS BLEEDING WAS OBSERVED FROM THE LEFT ATRIUM AND BYPASS WAS REINITIATED. A TEAR WAS LOCATED ALONG THE ROOF OF THE LEFT ATRIUM AND REPAIRED WITH FOUR PLEDGETED SUTURES. THE PATIENT WAS THEN WEANED OFF BYPASS AND RETURNED TO THE INTENSIVE CARE UNIT. FOUR HOURS POST PROCEDURE, THE PATIENT WAS UNABLE TO BE EXTUBATED AND EXHIBITED SIGN OF A STROKE. A COMPUTED TOMOGRAPHY SCAN REVEALED A LEFT CEREBRAL INFARCT. THROMBUS WAS REMOVED FROM THE LEFT MIDDLE CEREBRAL ARTERY, AND IT WAS DISCOVERED THAT THERE WAS A 90% STENOSIS OF THAT VESSEL. THE PATIENT WAS PLACED ON SUPPORTIVE CARE AND DIED ON THE FOURTH POST OPERATIVE DAY. WHILE ATRICURE CANNOT CONFIRM THAT DEVICE CAUSED OR CONTRIBUTED TO PATIENT'S COMPLICATION OR DEMISE, WE ARE REPORTING PER CFR 21 PART 803. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation; Stroke/CVA

  MAUDE report 20286897 ↗
• MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT HAD AORTIC VALVE REPAIR/REPLACEMENT AND AORTIC ROOT PROCEDURE, WITH CONCOMITANT ABLATION AND LEFT ATRIAL APPENDAGE EXCLUSION. AFTER COMPLETING ABLATION WITH OLH DEVICE, WHEN PHYSICIAN RELEASED THE DEVICE'S CLOSURE LEVER, THE BLUE PLUNGER INSERT ON THE LEVER DETACHED AND LANDED WITHIN THE STERILE FIELD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906939 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 AN 84-YEAR-OLD MALE PATIENT UNDERWENT AN ON-PUMP CORONARY ARTERY BYPASS GRAFT (CABG) WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) AND POSTERIOR WALL ENCIRCLING ABLATION USING AN OLH CLAMP DEVICE. DUE TO THE PATIENT HAVING AN ABNORMALITY WITH PULMONARY VEINS, SURGEON HAD A DIFFICULT TIME ROUTING THE OLH BEHIND THE HEART. DURING ONE ROUTING ATTEMPT, THE POSTERIOR ASPECT OF THE PATIENT'S HEART WAS PERFORATED. SURGEON ABORTED THE ABLATION PROCEDURE, CROSS-CLAMPED THE AORTA, AND REPAIRED THE INJURY WITH SUTURE AFTER WHICH HE SUCCESSFULLY COMPLETED THE CABG AND LAAE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 18332042 ↗
• MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023 A PATIENT UNDERWENT A MYECTOMY WITH CONCOMITANT MAZE USING AN OLH CLAMP. WHILE USING THE OLH, THE BLUE PLUNGER INSERT OF THE CLOSURE LEVER DETACHED AND FELL INTO STERILE FIELD, AWAY FROM CHEST CAVITY, AND THEN FELL TO THE FLOOR. PROCEDURE WAS COMPLETED WITH THE DEVICE AND THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113662 ↗
• MalfunctionOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR WALL ENCIRCLING ABLATION PROCEDURE. DURING REPOSITIONING/OPENING AND CLOSING CLAMP ONTO CARDIAC TISSUE, THE BLUE PLUNGER INSERT OF THE CLOSURE LEVER DETACHED. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO DELAY IN THE CASE, NOR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17924943 ↗
• MalfunctionOct 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, A PATIENT UNDERWENT AN AORTIC VALVE, MYECTOMY, AND CONCOMITANT MAZE PROCEDURE. DURING THE MAZE PORTION OF THE PROCEDURE, THE BLUE PLUNGER INSERT OF THE CLOSURE LEVER DETACHED WHEN THE CLAMP WAS RELEASED AND FELL INTO THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875912 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A FEMALE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT SURGERY WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION USING ATRICURE OLH CLAMP. WHILE POSITIONING THE CLAMP, BLOOD WAS OBSERVED, AND A TEAR WAS IDENTIFIED AT THE BASE OF THE LEFT ATRIAL APPENDAGE. DUE TO APPENDAGE MORPHOLOGY AS WELL AS INJURY LOCATION AND MINIMAL EXTENT OF BLEEDING, THE SURGEON WAS ABLE TO NON-EMERGENTLY CROSS-CLAMP THE AORTA, AFTER WHICH HE ELECTED TO EXCISE AND OVER SEW THE LEFT ATRIAL APPENDAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS REPORTEDLY DOING WELL IN THEIR RECOVERY. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 17760324 ↗
• MalfunctionJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) WITH POSTERIOR WALL ENCIRCLING ABLATION. DURING PROCEDURE, THE PLUNGER INSERT OF THE CLOSURE LEVER DETACHED AND FELL ON TO THE SURGICAL DRAPES. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361901 ↗