AtriCure Isolator Synergy EnCompass Clamp and Guide System OSHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10840143905995), received between Jan 8, 2026 and Jan 9, 2026 — classified as 2 deaths, 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY VIA MEDIAN STERNOTOMY WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION. DUE TO THE PATIENT¿S ANATOMY, THE CLAMP COULD NOT BE POSITIONED APPROPRIATELY AND THE SURGEON ELECTED TO ABANDON CONCOMITANT ABLATION. WHEN CLAMP WAS REMOVED, BLEEDING WAS NOTED, AND A PULMONARY ARTERY TEAR WAS IDENTIFIED. THE INJURY WAS REPAIRED WITH SUTURES. REPORTED INFORMATION INDICATES THAT THE PATIENT EXPERIENCED NO OTHER COMPLICATIONS. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 24030755 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) VIA MEDIAN STERNOTOMY WITH A PLANNED POSTERIOR WALL ENCIRCLING ABLATION USING AN OLH CLAMP. DUE TO THE PATIENT¿S ANATOMY, THE CLAMP COULD NOT BE POSITIONED APPROPRIATELY, AND THE SURGEON ELECTED TO ABANDON THE ABLATION. AFTER THE CLAMP WAS REMOVED, BLEEDING WAS NOTED, AND A PULMONARY ARTERY TEAR WAS IDENTIFIED. THE INJURY WAS REPAIRED INTRAOPERATIVELY WITH SUTURES, AND THE PATIENT EXPERIENCED NO POSTOPERATIVE COMPLICATIONS. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 24028090 ↗
• DeathJan 9, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT MITRAL VALVE REPLACEMENT (MVR) VIA MEDIAN STERNOTOMY WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION. INFORMATION PRESENTED INDICATES THAT PREVIOUSLY UNRECOGNIZED AMYLOID SCARRING WAS PRESENT ALONG THE DOME OF THE LEFT ATRIUM. DURING APPLICATION OF RADIOFREQUENCY (RF) ENERGY, AN INJURY TO LEFT ATRIUM OCCURRED IN THE AREA OF SCARRING. THE INJURY WAS UNABLE TO BE SUCCESSFULLY REPAIRED, AND THE PATIENT EXPIRED.THERE IS NO REPORTED DEVICE MALFUNCTION AND THE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24026632 ↗
• DeathJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 A 76-YEAR-OLD MALE PATIENT WITH A HISTORY OF AFIB AND MITRAL REGURGITATION UNDERWENT AN MVR VIA MEDIAN STERNOTOMY WITH POSTERIOR WALL ENCIRCLING ABLATION. PREVIOUSLY UNRECOGNIZED AMYLOID SCARRING WAS PRESENT ALONG THE DOME OF THE ATRIUM. DURING THE RADIOFREQUENCY (RF) ABLATION, AN ATRIAL INJURY OCCURRED. THE INJURY PROVED IRREPARABLE, AND THE PATIENT EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003548 ↗