ESSENZ Arterial Clamp- AC arm long (620 mm)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04033817903116), received between May 17, 2024 and Oct 31, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (9 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Unstable; Unstable

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438516 ↗
• MalfunctionJul 9, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455912 ↗
• MalfunctionJun 13, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT RELATED TO AN ISSUE OF AN ARTERIAL CLAMP USED ON AN ESSENZ CONSOLE. IN DETAIL, AT THE TIME OF DE-CLAMPING WITH POOR VENOUS RETURN THAT LED TO REPEATED LEVEL ALARMS CONSEQUENT CLOSURE OF THE ARTERIAL CLAMP OCCURRED. FOLLOWING ONE OF THESE ALARMS THE ARTERIAL CLAMP NO LONGER OPENED, GIVING ERROR MESSAGES RELATED TO "ARTERIAL CLAMP FAILED" (CODES 141 AND 1200).THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201645 ↗
• MalfunctionMay 9, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE ARTERIAL CLAMP WAS DEFECTIVE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992668 ↗
• MalfunctionMar 28, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PRE-OPERATION SAFETY TESTS, AN ESSENZ ARTERIAL CLAMP DID NOT CLOSE, NOR INDICATE A STATUS OF CLOSED ON THE COCKPIT OF THE CONSOLE AS EXPECTED WHEN THE LEVEL OR BUBBLE ALARM WERE TRIGGERED. AFTER SEVERAL ATTEMPTS TO VERIFY THE CONDITION BY THE USER, THE ARTERIAL CLAMP BEGAN TO FUNCTION CORRECTLY, THEREFORE IT WAS POSSIBLE TO CONTINUE WITH THE PRE-OPERATION SAFETY TESTS. THE CASE DID NOT REQUIRE THE PATIENT TO BE PLACED ON BYPASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718951 ↗
• MalfunctionFeb 21, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, AT THE EXIT FROM THE CEC, THE ARTERIAL CLAMP- AC ARM LONG DISPLAYED ALARM ARTERIAL CLAMP DEFECTIVE. THE PERFUSIONIST TRIED TO SILENCE THE ALARM, REMOVED THE TUBE FROM THE CLAMP AND REPLACED IT. AFTER REOPENING THE CLAMP FROM THE COCKPIT, FROM THERE NO MORE ALARMS. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21430802 ↗
• MalfunctionDec 3, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830137 ↗
• MalfunctionOct 25, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ARTERIAL CLAMP DISPLAYED "ARTERIAL CLAMP DEFECTIVE" MESSAGE DURING A PROCEDURE. MESSAGE SHOWN AND THE ARTERIAL CLAMP REMAINED COMPLETELY FUNCTIONAL. MESSAGE DISAPPEARED AFTER REBOOTING A COUPLE OF TIMES THE UNIT. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532388 ↗
• MalfunctionAug 23, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT OF A NOISY AND DEFECTIVE ESSENZ ARTERIAL CLAMP DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049833 ↗
• MalfunctionMay 17, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ARTERIAL CLAMP GAVE AN ERROR MESSAGE RELATED TO ITS DEFECTIVENESS DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338994 ↗