ESSENZ Arterial Clamp - AC arm short (500mm)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04033817903109), received between Jun 5, 2024 and Feb 25, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT ABOUT ALARM "ARTERIAL CLAMP DEFECTIVE" APPEARED ON AN ESSENZ COCKPIT, RELATED TO THE ESSENZ ARTERIAL CLAMP. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442623 ↗
• MalfunctionApr 28, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A DEMONSTRATION OF THE CENTRIFUGAL PUMP, THE ARTERIAL CLAMP DID NOT CLOSE ON A LEVEL ALARM. EVEN AFTER A COMPLETE RESTART, IT DIDN¿T REACT. THE LEVEL WAS REMOVED FROM THE PROFILE AND INSERTED IT AGAIN, AFTER THAT, THE ARTERIAL CLAMP REACTED AS IT SHOULD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917085 ↗
• MalfunctionMar 5, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT,, DURING PRIMING, THE ALARM ARTERIAL CLAMP PROBLEM WAS DISPLAYED. CUSTOMER PROVIDED PHOTOGRAFIC EVIDENCES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526467 ↗
• MalfunctionMar 5, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ARTERIAL CLAMP GAVE SOMETIMES THE FOLLOWING ERROR MESSAGE ON COCKPIT SCREEN OF THE ESSENZ CONSOLE: "ARTERIAL CLAMP: PROBLEM". IN ADDITION ALSO CONFIGURATION ERROR MESSAGES RELATED TO ARTERIAL PUMP AND CEREBRAL ONE APPEARED. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526436 ↗
• MalfunctionMar 5, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ARTERIAL CLAMP GAVE THE ERROR MESSAGE "ARTERIAL CLAMP DEFECTIVE" AT SETUP. THE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523858 ↗
• MalfunctionJun 5, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ARTERIAL CLAMP DISPLAYED ERROR ARTERIAL CLAMP DEFECTIVE-TIMEOUT OF THE ARTERIAL CLAMP (E2450) DURING SET UP. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465653 ↗

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