ESSENZ RP85Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04033817903086), received between Apr 5, 2023 and Sep 18, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 24, 2025Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSENZ ROLLER PUMP 85, USED AS BLOOD CARDIOPLEGIA (CPL-B) ONE, WAS DEFECTIVE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588365 ↗
• MalfunctionJul 21, 2025Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSENZ ROLLER PUMP 85, USED AS SUCTION PUMP, GAVE THE FOLLOWING ERROR MESSAGE: "SUCTION 3 PUMP ISSUE (REPLACE SUCTION 3 PUMP AFTER CASE)" DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561607 ↗
• MalfunctionJul 10, 2025Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466337 ↗
• MalfunctionMay 28, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSENZ ROLLER PUMP 85, USED FOR CRYSTALLOID CARDIOPLEGIA DELIVERY WITH 4:1 RATIO, DID NOT TURN AND AN ALARM WENT OFF. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096181 ↗
• MalfunctionMay 26, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084449 ↗
• MalfunctionFeb 19, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT, DURING A PROCEDURE, THE CARDIOPLEGIA ROLLER PUMP 85 NO LONGER WORKED. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411424 ↗
• MalfunctionOct 31, 2024Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ROLLER PUMP 85 DISPLAYED AN ALARM PUMP DEFECTIVE DURING A PROCEDURE. MEDICAL TEAM REPLACED THE CARDIOPLEGIA CRYSTAL PUMP. THERE IS NO REPORT OF ANY PATIENT INJURY. CUSTOMER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578102 ↗
• MalfunctionAug 7, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSENZ DOUBLE ROLLER PUMP GAVE AN ERROR MESSAGE ('PUMP DEFECTIVE') AND WOULD NOT TURN WHEN STARTED DURING PROCEDURE. NOT RESPONSE EVEN WHEN OPERATED AFTER SEVERAL ATTEMPTS. THEREFORE, PUMP WAS SWAPPED OUT WITH A LOANER ONE BY THE CUSTOMER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928099 ↗
• MalfunctionMar 20, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939212 ↗
• MalfunctionApr 5, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ESSENZ DOUBLE HEAD PUMP, USED AS SUCTION PUMP, STOPPED DURING A PEDIATRIC CASE AND GAVE A RUNAWAY ERROR MESSAGE (THE PUMP RAN TOO FAST - SET VALUE DIFFERENT TO ACTUAL VALUE). THE CUSTOMER UNPLUGGED AND RE-PLUGGED THE CONNECTION CABLE OF THE INVOLVED PUMP, THEN THE PUMP RAN FOR TWENTY (20) SECONDS BEFORE STOPPING AGAIN AND GIVING THE SAME ERROR MESSAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681605 ↗

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