ESSENZ Venous clampRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04033817903093), received between Oct 5, 2023 and Sep 25, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (17 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 22 most recent of 22 reports, 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 ↗
• MalfunctionAug 4, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125986 ↗
• 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 9, 2026Unstable

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT ABOUT AN ELECTRONIC ESSENZ VENOUS CLAMP (EVO), WHOSE CONTROL UNIT SHOWED 39% OPENING VALUE WHILE IT WAS CLOSED, DESPITE HAVING BEEN CALIBRATED. ON ANOTHER OCCASION, THE CLAMP INDICATED 1% OPENING VALUE WHILE IT WAS FULLY OPEN. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544923 ↗
• MalfunctionFeb 6, 2026Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ERROR MESSAGE 2551 'VENOUS CLAMP DEFECTIVE' CONCERNING AN ESSENZ VENOUS CLAMP APPEARED ON THE SCREEN DURING PRIMING. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279389 ↗
• MalfunctionDec 30, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ESSENZ VENOUS CLAMP WAS NOT WORKING PROPERLY AND ERROR CODE 2551 WAS SHOWED. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920522 ↗
• MalfunctionDec 29, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ERROR MESSAGE RELATED TO AN ESSENZ VENOUS CLAMP DISPLAYED ONTO THE UNIT ("VC DEFECTIVE"). SUBSEQUENTLY, THE CLAMP WAS CALIBRATED AND COULD WORK PROPERLY. THE EVENT OCCURRED OUT OF PROCEDURE.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904696 ↗
• MalfunctionDec 5, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728166 ↗
• MalfunctionNov 28, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23672106 ↗
• MalfunctionNov 5, 2025Unstable; Unstable

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479254 ↗
• MalfunctionSep 3, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950219 ↗
• MalfunctionJun 20, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE VENOUS CLAMP MALFUNCTIONED. THE ESSENZ COCKPIT DISPLAYED RED BOX WITH A GEAR AND AN UNLINKED ICON. CUSTOMER HAD TO REMOVE THE TUBING FROM THE CLAMP AND MANUALLY CLAMP. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297992 ↗
• MalfunctionMay 9, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, IT IS NOT POSSIBLE TO MODIFY THE STATUS OF THE VENOUS CLAMP: WHEN THEY TURN IT ON THEY FEEL THAT THE CLAMP DOES SOMETHING INSIDE MECHANICALLY, BUT THE PISTON DOES NOT MOVE AND REMAINING STILL EVEN AFTER SEVERAL ATTEMPTS TO TURN THE SYSTEM ON AND OFF, WITH ALSO CONSEQUENT CHANGE OF DOOR IN THE POWER-PACK, THE PROBLEM REMAINS. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992761 ↗
• MalfunctionMar 25, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685595 ↗
• MalfunctionFeb 11, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT RELATED TO A VENOUS CLAMP ISSUE DURING PROCEDURE. EVEN IF 20% OPENING WAS REQUESTED, THE CLAMP WAS 100% OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353084 ↗
• MalfunctionJan 10, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122423 ↗
• MalfunctionOct 31, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE VENOUS CLAMP BEHAVED AS NO LONGER CALIBRATED AND WAS NOT OCCLUDING CORRECTLY: AT 0.9%, THE BLOOD FLOW METER MEASURED MORE THAN 2 LITERS OF VENOUS RETURN. ALARM 156 WAS DISPLAYED ACCORDING TO PERFUSIONIST, THE EVENT HAS ALREADY PREVIOUSLY OCCURRED WITHOUT CAUSING ALARM AS IN THIS CASE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578260 ↗
• MalfunctionSep 3, 2024Unstable; Unstable

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125732 ↗
• MalfunctionAug 8, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938393 ↗
• MalfunctionJun 20, 2024Calibration Problem; Difficult to Open or Close; Calibration Problem; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSSENZ ELECTRICAL VENOUS OCCLUDER (EVO) BEHAVES ERRATICALLY: IT DOES NOT PROVIDE CONSISTENT CLAMPING AND OCCASIONALLY OPENS OR CLOSES ON IT'S OWN. THE UNIT IS IN USE AT A PERFUSION SCHOOL LABORATORY AND NOT IN A CLINICAL SETTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575031 ↗
• MalfunctionOct 5, 2023Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSENZ ELECTRICAL VENOUS OCCLUDER (EVO) GAVE AN ERROR MESSAGE AT SETUP RELATED TO ITS MOTOR DEFECTIVE. ONCE THE ALARM HAS BEEN CLEARED, THE UNIT CONTINUED TO WORK PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876409 ↗

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