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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143904110), received between Apr 27, 2022 and Apr 27, 2022 — classified as 1 death.

The most frequently reported specific device problem is “Positioning Failure” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 27, 2022Positioning Failure; Positioning Failure

  ON (B)(6) 2022 A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, HYPERTENSION, DIABETES, AND KIDNEY DISEASE UNDERWENT A 3-VESSEL CORONARY ARTERY BYPASS GRAFT (CABG) SURGICAL PROCEDURE WITH CONCOMITANT RF ABLATION. AFTER ROUTING THE ENCOMPASS CLAMP, THE PHYSICIAN LIFTED THE HEART TO VISUALIZE THE CLAMP JAW LOCATION BUT COULD NOT VISUALIZE THE LOWER CLAMP JAW. FURTHER INSPECTION REVEALED AN INJURY TO THE RIGHT INFERIOR PULMONARY VEIN WHICH WAS REPAIRED WITH 2-PLEDGETED SUTURES. THAT NIGHT, THE PATIENT SHOWED SIGNS AND SYMPTOMS OF A STROKE. CT TESTING CONFIRMED AN EMBOLIC STROKE AND PATIENT ULTIMATELY EXPIRED ON (B)(6) 2022. THERE IS NO CONFIRMED CAUSAL LINK BETWEEN THE RF ABLATION AND THE STROKE. CONTRIBUTION FROM THE RF ABLATION PROCEDURE CANNOT BE RULED OUT, SO THIS EVENT IS BEING REPORTED PER PART 803. THIS WAS A PROCEDURAL COMPLICATION AND THERE WAS NO REPORTED DEVICE MALFUNCTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 14218670 ↗