ESSENZ HLMRecalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 04033817903062), received between Nov 3, 2023 and Sep 24, 2026 — classified as 1 death, 4 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 18, 2024Open, Classified

   Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

   Z-0571-2025 · Root cause: Software change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884955 ↗
• MalfunctionSep 24, 2026Application Program Problem

  LivaNova Deutschland received report that Essenz HLM cockpit rebooted by itself during procedure. Reportedly, the pump remained controllable using the backup control unit. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884930 ↗
• MalfunctionSep 23, 2026Difficult to Open or Close

  LivaNova Deutschland received a report that Essenz venous clamp (VC) was not working properly, even if it was calibrated. As troubleshooting, the tube was removed and then placed in again but the problem was not solved.There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870563 ↗
• MalfunctionSep 21, 2026Application Program Problem

  LivaNova Deutschland received report that, before initiating procedure, Essenz HLM cockpit rebooted by itself.Reportedly, perfusionist started a new case and the procedure was completed without further problems.There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836341 ↗
• MalfunctionSep 16, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785633 ↗
• MalfunctionMar 30, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A SUCKER PUMP OF AN ESSENZ HEART-LUNG MACHINE (HLM) WAS NOT WORKING. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712222 ↗
• MalfunctionMar 30, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT SUCKER AND VENT PUMPS OF AN ESSENZ HEART-LUNG MACHINE (HLM) WERE NOT WORKING. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712216 ↗
• MalfunctionMar 19, 2026Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A ESSENZ BUBBLE SENSOR WHICH COULD NOT PROPERLY FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637224 ↗
• MalfunctionMar 13, 2026Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ESSENZ HEART-LUNG MACHINE (HLM) COCKPIT HAS UNEXPECTEDLY REBOOTED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591224 ↗
• MalfunctionMar 12, 2026Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ESSENZ HEART-LUNG MACHINE COCKPIT REBOOT DURING THE PROCEDURE. DURING THE OCCURRENCE, THE COCKPIT SCREEN TURNED BLACK, BUT IMMEDIATELY IT RETURNED TO THE HOME SCREEN. IT WAS ALSO REPORTED THAT THE CENTRIFUGAL PUMP AND ROLLER PUMPS CONTINUED TO OPERATE WHILE THE SYSTEM REBOOTED ITSELF, AND AFTER CLICKING BACK INTO THE CASE, THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583437 ↗
• MalfunctionFeb 11, 2026Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ESSENZ HLM COCKPIT FROZE AFTER CASE AND REBOOTED. THE EVENT OCCURRED AT THE END OF PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314643 ↗
• MalfunctionJan 9, 2026Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED REPORT OF AN ESSENZ HLM COCKPIT SHOWING THE ERROR MESSAGE: ARTERIAL CLAMP DEFECTIVE ERROR 1200. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020923 ↗
• MalfunctionJan 7, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED REPORT THAT THE ESSENZ HLM COCKPIT SHOWED TWO ERRORS WHILE ON BYPASS: PUMP DEFECTIVE (E2350) AND PUMP ISSUE (E2353). THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989430 ↗
• MalfunctionDec 19, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848531 ↗
• MalfunctionDec 18, 2025Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ESSENZ HLM COCKPIT REBOOTED DURING PROCEDURE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836094 ↗
• MalfunctionDec 17, 2025Application Program Problem; Application Program Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ESSENZ COCKPIT RESTART. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826808 ↗
• MalfunctionDec 17, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ESSENZ ARTERIAL CLAMP WAS NOT WORKING PROPERLY. REPORTEDLY, THE PLASTIC FIXTURE THAT ENGAGES WHEN OPENING OR CLOSING THE CLAMP WAS NOT MOVING. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826751 ↗
• MalfunctionDec 10, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770506 ↗
• MalfunctionDec 10, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770484 ↗
• MalfunctionDec 10, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PRELIMINARY TESTING OF THE LEVEL ALARM, THE ARTERIAL PUMP DID NOT DROP TO 1400 ROUNDS PER MINUTES (RPM) BUT SUDDENLY STOPPED. PERFUSION REBOOTED THE HLM, REPEATED THE TEST AND PASSED POSITIVELY. THE EVENT OCCURRED DURING INITIAL SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767801 ↗
• MalfunctionDec 5, 2025Structural Problem; Structural Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ESSENZ HLM VENOUS CLAMP (VC) WAS NOT WORKING PROPERLY. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727970 ↗
• MalfunctionDec 5, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727949 ↗
• MalfunctionDec 5, 2025Device Sensing Problem; Device Sensing Problem

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727905 ↗
• MalfunctionDec 3, 2025Application Program Problem; Application Program Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706075 ↗
• MalfunctionNov 28, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ESSENZ HEART LUNG MACHINE ARTERIAL PUMP STOPPED WHILE AT LOW FLOW VALUES. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669567 ↗