ESSENZ CPDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04033817903031), received between Jun 11, 2025 and Oct 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Auto Stop” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED REPORT OF AN INTERMITTENT ALARM ("ARTERIAL PUMP DEFECTIVE", 142) REFERRED TO A CENTRIFUGAL PUMP DRIVE MOUNTED ONTO ESSENZ HEART-LUNG MACHINE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359878 ↗
• MalfunctionSep 5, 2025Increased Pump Speed; Increased Pump Speed

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE CENTRIFUGE PUMP USED ON ESSENZ HEART LUNG MACHINE (HLM) STARTED ON ITS OWN, DURING PRIMING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978840 ↗
• MalfunctionJun 13, 2025Pumping Stopped; Pumping Stopped

  DURING PREPARATION FOR THE ESSENZ DEMO, AN ALARM OCCURRED FOR "DEVICE (E2911) PUMP FAILURE." THE ALARM HISTORY SHOWS "ART PUMP FAILURE (E142)" AND "ART PUMP PROBLEM (E2353)." PHOTOS AND ERROR LOGS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201342 ↗
• MalfunctionJun 11, 2025Failure to Auto Stop; Failure to Auto Stop

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, AT THE END OF THE PROCEDURE, AFTER HAVING RECOVERED PATIENT BLOOD STILL INSIDE THE ARTERY LINE, THE ESSENZ CENTRIFUGAL PUMP BLOCKED AT 1400 RPM SPED AND DIT NOT ALLOW THE OPERATOR TO BRING IT TO 0 RPM. OPERATOR OVERCOME THE PROBLEM AFTER SEVERAL ATTEMPTS. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187026 ↗

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