ESSENZ CockpitRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04033817903048), received between Sep 10, 2024 and Mar 3, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K232291); they may or may not involve this specific model.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT CONCERNING AN ESSENZ HLM COCKPIT THAT REBOOTED WHEN THE CUSTOMER SWITCHED FROM PRE-BYPASS MODE TO BYPASS MODE, PRIOR TO INITIATING EXTRACORPOREAL CIRCULATION. SPECIFICALLY, IT WAS REPORTED THAT THE COCKPIT BRIEFLY BLACKED OUT FOR A FEW SECONDS, AND SUBSEQUENTLY RETURNED TO NORMAL OPERATION WITHOUT ANY USER INTERVENTION. REPORTEDLY, PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO IMPACT ON THE PATIENT OR THE USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501407 ↗
• MalfunctionNov 24, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633412 ↗
• MalfunctionNov 24, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED REPORT OF AN ESSENZ HLM COCKPIT WHOSE KNOBS STOPPED OPERATING DURING PRIMING. SYSTEM WAS REBOOTED, BUT THE ISSUE PERSISTED. AFTER 4 MINUTES, THE COCKPIT SCREEN SHOWED UP. DURING THAT TIME ONLY THE ARTERIAL KNOB WORKED. THE BACK-UP CONTROL PANEL WAS NEVER USED AS TRIAL. CASE WAS THEN COMPLETED SUCCESSFULLY. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632908 ↗
• MalfunctionNov 18, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580019 ↗
• MalfunctionNov 13, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543874 ↗
• MalfunctionNov 12, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530058 ↗
• MalfunctionOct 15, 2025Application Program Problem; Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED REPORT OF AN ESSENZ HLM COCKPIT WHICH TURNED GRAY AND UNRESPONSIVE WHILE CHANGING THE HEATER/COOLER PARAMETERS ONTO THE DISPLAY, THEN, AFTER A FEW SECONDS, THE SCREEN RETURNED TO THE PROFILE SELECTION SETTINGS. THE EVENT OCCURRED DURING PROCEDURE, APPROXIMATELY ONE HOUR AFTER THE START OF EXTRACORPOREAL CIRCULATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298824 ↗
• MalfunctionSep 25, 2025Application Program Problem; Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ESSENZ HLM CONSOLE COCKPIT REBOOTED TWICE WITHIN FEW MINUTES. THE EVENT OCCURRED DURING PROCEDURE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151720 ↗
• MalfunctionAug 11, 2025Computer Software Problem; Computer Software Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING WEANING FROM BYPASS PROCEDURE, THE ESSENZ COCKPIT SCREEN WENT BLACK. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769050 ↗
• MalfunctionJul 7, 2025Application Program Problem; Application Program Problem

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410090 ↗
• MalfunctionJul 2, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383477 ↗
• MalfunctionJun 26, 2025Application Program Problem; Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A COCKPIT REBOOT OF AN ESSENZ CONSOLE JUST BEFORE CROSS CLAMP APPLICATION. THE MONITOR TURNED OFF, AND AFTER A FEW SECONDS, IT TURN BACK ON. DURING THIS TIME, THE PUMP CONTINUED TO TURN AND THE GAS BLENDER RETURNED TO DEFAULT VALUES AS PER USER PROFILE CONFIGURATION (0LPM AND 21% FIO2). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338021 ↗
• MalfunctionMay 23, 2025Application Program Problem; Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, AT THE END OF THE CASE, THE COCKPIT SCREEN OF AN ESSENZ CONSOLE WAS FROZEN. IT WAS TRIED TO LOWER THE ARTERIAL FLOW, BUT IT WAS NOT VISIBLE ON THE SCREEN. THEN, THE FLOW WAS LOWERED THROUGH THE BACKUP CONTROL UNIT, WHICH WAS ALSO NOT VISIBLE ON THE COCKPIT SCREEN. AFTER SIXTY (60) SECONDS SUDDENLY THE COCKPIT REBOOTED BY ITSELF AND FUNCTIONED AGAIN. THEN THE LOWERED FLOW WAS VISIBLE AGAIN ON THE COCKPIT (THE FLOW WAS APPARENTLY LOWERED, BUT THAT WAS NOT VISIBLE ON THE COCKPIT WHERE THE VALUE WAS STILL THE SAME UNTIL IT REBOOTED). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076620 ↗
• MalfunctionFeb 25, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458343 ↗
• MalfunctionNov 20, 2024Computer Software Problem; Computer Software Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A COCKPIT RESET OF AN ESSENZ CONSOLE EQUIPPED WITH SOFTWARE VERSION 1.5 OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732189 ↗
• MalfunctionNov 15, 2024Computer Software Problem; Computer Software Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A COCKPIT RESET OF AN ESSENZ CONSOLE EQUIPPED WITH SOFTWARE VERSION 1.5 OCCURRED DURING PROCEDURE. PERFUSIONIST SAW THE SAO2 AND PO2 DROPPED DURING REBOOT. AFTER PUSHING THE BUTTON "LAST CASE" THE COCKPIT WAS WORKING AGAIN NORMALLY. PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693056 ↗
• MalfunctionNov 6, 2024Computer Software Problem; Computer Software Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A COCKPIT RESET OF AN ESSENZ CONSOLE EQUIPPED WITH SOFTWARE VERSION 1.5 OCCURRED DURING PROCEDURE. AFTER PUSHING THE BUTTON "LAST CASE" THE COCKPIT WAS WORKING AGAIN NORMALLY. THE GAS FLOW OF THE GAS BLENDER WAS ALSO INTERRUPTED DURING THE REBOOT TIME (ABOUT 20 SECONDS ACCORDING TO THE PERFUSIONIST). AFTER THIS REBOOT TIME THE GAS FLOW WAS ALSO BACK. THE PROCEDURE ENDED WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620156 ↗
• MalfunctionSep 10, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, AT THE MOMENT OF DELIVERY OF THE SECOND CARDIOPLEGIA DOSE, THE ESSENZ COCKPIT GOT FROZEN (AT 12:23). THE KNOBS IN THE COCKPIT WERE NOT DRIVING THE PUMPS. HOWEVER, CARDIOPLEGIA COULD BE ADMINISTERED TO THE PATIENT USING THE BACKUP CONTROL PANEL KNOB. MEANWHILE, COCKPIT BECOME TOTALLY BLACK AND RESTART SHOWING THE FIRST PAGE AS THE ONE THAT APPEARS WHEN THE HLM IS SWITCHED ON. THE PERFUSIONIST DOES NOT REMEMBER IF THE BUTTON ¿LAST CASE¿ WAS AVAILABLE AND HE PRESSED "NEW CASE" AND DISTRIBUTED THE NEEDED PROFILE. WHEN THE PROFILE HAS BEEN DISTRIBUTED THE PERFUSIONIST PRESSED START CASE (SKIPPING THE SAFETY CHECK) AND EVERYTHING WAS STILL WORKING. ONLY THE TIMERS WERE AT ZERO, AT THAT MOMENT, AND THE EGB BEEPING AS IT HAPPENS WHEN THE VALUES STORED IN THE PROFILE ARE SENT TO IT. FROM THAT POINT HE WAS ABLE TO REACH THE END FOR THE PROCEDURE WITHOUT ANY OTHER ISSUE. PERFUSION WAS GUARANTEED AT ALL TIMES. THERE IS NO REPORT OF ANY PATIENT INJURY. ON AUGUST 11, 2024, LIVANOVA WAS INFORMED ALSO THE GAS BLENDER HAD FROZEN AND AFTER RESTART THE FLOW HAD TO BE MANUALLY RE-ADJUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20178093 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232291. One submission often covers many models, so check the product and lot details in each record.

• Z-0571-2025 · Oct 18, 2024 · Open, Classified
  Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software