ESSENZRecalls & reported problems across all models

We found 8 models of ESSENZ by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 185 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2023 and Sep 25, 2026 — classified as 1 death, 4 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (40 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ESSENZ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

Most reported ESSENZ problems

ESSENZ models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ESSENZ HLM

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 recall1 death110 reports
• ESSENZ Venous clamp

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  22 reports
• ESSENZ Cockpit

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  18 reports
• ESSENZ RP85

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  11 reports
• ESSENZ Arterial Clamp- AC arm long (620 mm)

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  10 reports
• ESSENZ Arterial Clamp - AC arm short (500mm)

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  6 reports
• ESSENZ RP150

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  4 reports
• ESSENZ CPD

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  4 reports

Recent ESSENZ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Open or Close

  LivaNova Deutschland received a report that the Essenz Venous Clamp (VC) displayed an error code indicating that the clamp was defective (E2551). The issue occurred during the procedure. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897289 ↗
• 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 18, 2026Pumping Stopped

  LivaNova Deutschland received a report that Essenz HLM CPL-C pump displayed an error code indicating that the pump was not working properly (2335). Reportedly, the error could not be cleared despite powering down and rebooting the HLM system.The affected roller pump was then replaced with a loan unit. The event occurred during priming.There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814442 ↗
• MalfunctionSep 16, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785633 ↗
• MalfunctionAug 4, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125986 ↗
• 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 25, 2026Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSENZ HEART-LUNG MACHINE (HLM) VENOUS CLAMP (VC) DISPLAYED THE ERROR MESSAGE "VC DEFECTIVE" (ERROR CODE 2551). THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688631 ↗
• MalfunctionMar 23, 2026Unstable

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT ABOUT MULTIPLE ERROR MESSAGES "VENOUS CLAMP DEFECTIVE" RELATED TO THE AN ESSENZ ELECTRONIC VENOUS CLAMP (EVO), DISPLAYED ON THE RELATIVE ESSENZ HLM CONSOLE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664975 ↗
• 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 ↗

Other LivaNova Deutschland GmbH products

• Heater-Cooler System2 models · 311 reports · 1 recall
• CP54 models · 96 reports · 1 recall
• S5 Console7 models · 141 reports
• S5 Roller Pump 1502 models · 135 reports
• Electronic Gas Blender3 models · 106 reports
• Electrical Remote-Controlled Tubing Clamp3 models · 85 reports
• S5 Double Roller Pump 852 models · 59 reports
• S5 Mast Roller Pump4 models · 47 reports