Synergy™ Ablation System OLL2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818354010503), received between Oct 16, 2018 and Jul 7, 2022 — classified as 1 death, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A PATIENT UNDERWENT AN ON-PUMP ASCENDING AORTA GRAFT WITH PULMONARY VEIN ISOLATION AND LEFT ATRIAL APPENDAGE EXCLUSION. WHEN THE SURGEON WAS ATTEMPTING TO GO AROUND THE LEFT PULMONARY VEINS TO PERFORM A PULMONARY VEIN ISOLATION USING THE OLL2 CLAMP, AN UNINTENDED PERFORATION WAS MADE. SURGEON SUTURED THE PERFORATION, AND NO COMPLICATIONS WERE OBSERVED. THE PULMONARY VEIN ISOLATION WAS THEN ABORTED. IT WAS NOTED THAT THE PATIENT HAD A LARGE AORTIC ANEURYSM WHICH MADE VISIBILITY AND ACCESS DIFFICULT. POST-OP THE PATIENT WAS DOING WELL. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Great Vessel Perforation

  MAUDE report 14950448 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A (B)(6) MALE PATIENT UNDERWENT A HEPARINIZED, ON-PUMP, ARRESTED MITRAL VALVE REPLACEMENT VIA TRANS SEPTAL APPROACH. A OLL2 CLAMP WAS PLACED AND THE PHYSICIAN DELIVERED 3 SETS OF TWO PARALLEL ABLATIONS. DURING THE PROCEDURE WHILE ABLATING THE PULMONARY VEINS, A TEAR WAS NOTICED ON THE ATRIUM. THE PHYSICIAN REPAIRED THE TEAR AND SURGICAL PROCEDURE WAS PROLONGED 15 MINUTES FOR EACH SIDE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12977446 ↗
• DeathOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AN (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT AN ON-PUMP, HEPARINIZED INTRA-AORTIC BALLOON PUMP INSERTION, MAMMARY TAKE DOWN, TRIPLE CORONARY ARTERY BYPASS GRAFT, BI-ATRIAL MAZE, A LEFT ATRIAL APPENDAGE LIGATION, AND AORTIC VALVE REPLACEMENT. UPON COMPLETION OF THESE PROCEDURES WHILE COMING OFF CARDIOPULMONARY BYPASS, BLEEDING WAS NOTED. THE PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS, AND THE HEART WAS RE-ARRESTED TO REPAIR THE LEFT ATRIAL ROOF LINE. PATIENT WAS STABLE POST-PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 12605208 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 21-OCT-2019 THAT A (B)(6) FEMALE PATIENT WITH A HISTORY OF ACTIVE ATRIAL FIBRILLATION AND MITRAL REGURGITATION, UNDERWENT A MITRAL VALVE REPAIR/REPLACEMENT, TRICUSPID VALVE REPAIR, PULMONARY VEIN ISOLATION AND LEFT ATRIAL APPENDAGE MANAGEMENT. PRIOR TO THE PROCEDURE, A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED, THERE WAS NO EVIDENCE OF CLOTS WITHIN THE LEFT ATRIAL APPENDAGE AND LEFT ATRIUM. SURGEON USED THE OLL2 FOR THE PULMONARY VEIN ISOLATION. UPON REMOVING THE CLAMP, THE SURGEON NOTED THAT THE LEFT PULMONARY VEIN HAD A SMALL HOLE IN IT. THE SURGEON THEN SUTURED THE HOLE AND BLEEDING STOPPED. SURGEON ALSO VERIFIED THAT THE HOLE WAS NOT LOCATED IN AN AREA WHERE THE SURGEON WAS USING THE OLL2 FOR ABLATIONS, BUT ON THE LEFT PULMONARY VEIN. THE SURGERY WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Perforation

  MAUDE report 9343705 ↗
• MalfunctionFeb 5, 2019Appropriate Device Problem Term/Code Not Available

  DURING ABLATION, THE ATRICURE WAS PLACED OVER THE TISSUE DURING ATTEMPTED ABLATION. THE ABLATION LINE (BURN) ON THE MONITOR NEVER DROPPED BELOW BASELINE INDICATING THE BURN WAS NEVER COMPLETED. ANOTHER DEVICE WAS UTILIZED WITHOUT ISSUE. THIS PATIENT WAS NOT NEGATIVELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8304257 ↗
• MalfunctionFeb 4, 2019Appropriate Device Problem Term/Code Not Available

  ON THE FIRST ATTEMPT/LOCATION THE INSTRUMENT WORKED PROPERLY. THE SECOND ATTEMPT/LOCATION THE INSTRUMENT WOULD NOT COMPLETE NOR WOULD IT BEEP. THE PHYSICIAN ATTEMPTED MORE TIMES AND COULD NOT GET THE DESIRED EFFECT. INSTRUMENT WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW ONE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8306050 ↗
• MalfunctionOct 16, 2018Display or Visual Feedback Problem; Protective Measures Problem

  THE RADIOFREQUENCY (RF) ATRICURE PROBE WAS HAVING ISSUES. UNABLE TO COMPLETE THE ABLATION WITH THIS PROBE, AND RF MACHINE WAS SHOWING ABNORMAL WAVEFORMS. THE UNIT DISPLAYED AN ERROR CODE, AND A PICTURE OF THIS WAS SENT TO THE REP. THE PATIENT WAS ON THE PUMP, AND HEPARINIZED. THERE WAS A SURGICAL DELAY OF 5 TO 10 MINUTES. THE MAZE PROCEDURE WAS THEN ABLE TO BE COMPLETED AFTER OPENING ANOTHER OLL2 ATRICURE AND PULLED ANOTHER RF MACHINE. THE ASU (ABLATION SENSING UNIT) HAD BEEN USED ONCE PRIOR TO THIS PROBLEM. MANUFACTURER RESPONSE FOR SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION, SYNERGY ABLATION SYSTEM (PER SITE REPORTER). THEY REQUESTED INFORMATION REGARDING THE CASE AND HAVE PROVIDED A SHIPPER KIT TO RETURN THE DEVICE TO THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7968645 ↗