Heater-Cooler System 3T 120V ~ / 60HzRecalls & reported problems
LivaNova Deutschland GmbH · Class 2
All models of Heater-Cooler System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This LivaNova 3T heater-cooler system regulates temperature during heart bypass surgery. The 285 reports often describe temperature problems, pumping problems and microbial contamination of the unit, and some describe patient bacterial infections. The reports include 8 deaths and 13 injuries. There is 1 open recall, started in August 2023, over incorrect maintenance schedule information in its quick reference guide.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 277
- Deaths reported
- 8
- Injuries reported
- 15
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 277 adverse event reports that list this exact device (DI 04033817900528), received between Jul 20, 2016 and Sep 29, 2026 — classified as 8 deaths, 15 injuries, 252 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (66 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Aug 3, 2023Class IIOpen, Classified
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Z-0073-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Temperature Problem66
- Microbial Contamination of Device52
- Pumping Problem36
- Insufficient Heating24
- Appropriate Device Problem Term/Code Not Available22
- Electrical Shorting13
- Insufficient Cooling11
- Pumping Stopped11
Patient problems
- No Clinical Signs, Symptoms or Conditions200
- No Patient Involvement35
- Bacterial Infection23
- No Consequences Or Impact To Patient17
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 277 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928698 ↗MalfunctionSep 21, 2026Unexpected Shutdown
LivaNova Deutschland received a report of a 3T Heater/Cooler which suddenly shut off during usage. The event occurred during a procedure.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836112 ↗InjurySep 17, 2026Microbial Contamination of Device
LivaNova received a report alleging that a Heater-Cooler System 3T device was used during a cardiac surgery performed on (b)(6) 2019 on the plaintiff patient, that resulted infected by Mycobacterium Chimaera on (b)(6) 2025. Patient is alive.
Patient problems: Bacterial Infection
MAUDE report 50802319 ↗InjurySep 17, 2026Microbial Contamination of Device
LivaNova received a report alleging that a Heater-Cooler System 3T device was used during a cardiac surgery performed on (b)(6) 2019 on the plaintiff patient, that resulted infected by Mycobacterium Chimaera on (b)(6) 2025. Patient is alive.
Patient problems: Bacterial Infection
MAUDE report 50802313 ↗MalfunctionSep 15, 2026Temperature Problem
LivaNova Deutschland received a report of a 3T Heater/Cooler for which an error message was displayed (E07, "Pump 1 is blocked (too slow)"). The event occurred during procedure.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773484 ↗MalfunctionSep 10, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716266 ↗MalfunctionSep 8, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671901 ↗MalfunctionJul 29, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072774 ↗MalfunctionJun 25, 2026Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT HEATER COOLER 3T SYSTEM PATIENT DISPLAYED ALARM E07 (PUMP IS BLOCKED) ON PATIENT SIDE DURING PROCEDURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621098 ↗MalfunctionJun 4, 2026Pumping Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT HEATER COOLER 3T SYSTEM PATIENT PUMPS WERE FOUND TO BE DEFECTIVE DURING SERVICE INTERVENTION. REPORTEDLY SEVERAL ERROR CODES WERE ALSO DISPLAYED. TO SOLVE THE ISSUE, DISTRIBUTION BOARD WAS REPLACED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25389653 ↗MalfunctionApr 23, 2026Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE HEATER COOLER 3T SYSTEM SHOWED THE ERROR CODE E17, INDICATING A PUMP WAS NOT WORKING. THE EVENT OCCURRED DURING PROCEDURE. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24969446 ↗MalfunctionApr 15, 2026Temperature Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE HEATER COOLER 3T SYSTEM WAS NOT COOLING PROPERLY AND SEEMED TO BE STUCK. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883098 ↗MalfunctionApr 14, 2026Insufficient Heating
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE HEATER COOLER 3T SYSTEM PATIENT SIDE HEATING FUNCTION WAS NOT WORKING PROPERLY. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874445 ↗MalfunctionMar 30, 2026Pumping Problem
LIVANOVA DEUTSCHLAND RECEIVED REPORT REGARDING A HEATER COOLER 3T SYSTEM SHOWING THE ERROR (E16) CONCERNING PATIENT CIRCUIT 1. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712940 ↗MalfunctionMar 26, 2026Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE HEATER COOLER 3T SYSTEM DISPLAYED ALARM PUMP 1 USES TOO MUCH POWER (E06) AND IS BLOCKED ON MACHINE PATIENT SIDE. BURNING SMELL WAS ALSO REPORTED. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699951 ↗MalfunctionMar 13, 2026Temperature Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24598124 ↗MalfunctionMar 6, 2026Temperature Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT REGARDING A HEATER COOLER 3T SYSTEM, SHOWING THE ERROR E04 REPORTING THAT THE TEMPERATURE DIFFERENCE OF THE TEMPERATURE SENSORS IN THE CONTROL/SAFETY SYSTEM IS TOO BIG. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528650 ↗MalfunctionMar 6, 2026Pumping Problem
LIVANOVA DEUTSCHLAND RECEIVED REPORT REGARDING A HEATER COOLER 3T SYSTEM, SHOWING THE ERROR (E16) CONCERNING FAULTY PUMP 2 IN PATIENT CIRCUIT 1. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528609 ↗MalfunctionFeb 27, 2026Temperature Problem
LIVANOVA DEUTSCHLAND RECEIVED REPORT THAT THE HEATER COOLER 3T SYSTEM HEATING FUNCTION WAS NOT WORKING PROPERLY. REPORTEDLY, DEVICE STOPPED AT 27°C EVEN IF SET TEMPERATURE WAS 37°C. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468836 ↗InjuryFeb 27, 2026Microbial Contamination of Device
LIVANOVA DEUTSCHLAND RECEIVED A REPORT IN WHICH IT IS ALLEGED THAT A HEATER-COOLER 3T SYSTEM CAUSED PATIENT MYCOBACTERIUM CHIMAERA INFECTION DURING A CABG PROCEDURE ON (B)(6) 2018. THE SURGERY OCCURRED AT (B)(6) HOSPITAL. THE PATIENT TESTED POSITIVE TO MNT CHIMAERA ON (B)(6) 2025 WITH LAB RESULTS CONFIRMED BY NATIONAL JEWISH.
Patient problems: Bacterial Infection
MAUDE report 24468216 ↗InjuryFeb 27, 2026Microbial Contamination of Device
LIVANOVA DEUTSCHLAND RECEIVED A REPORT IN WHICH IT IS ALLEGED THAT A HEATER-COOLER 3T SYSTEM CAUSED PATIENT MYCOBACTERIUM CHIMAERA INFECTION DURING A CABG PROCEDURE ON (B)(6) 2018. THE SURGERY OCCURRED AT (B)(6) HOSPITAL. THE PATIENT TESTED POSITIVE TO MNT CHIMAERA IN (B)(6) 2025 WITH LAB RESULTS CONFIRMED BY (B)(6).
Patient problems: Bacterial Infection
MAUDE report 24468211 ↗MalfunctionFeb 19, 2026Temperature Problem
LIVANOVA RECEIVED A REPORT OF A HEATER-COOLER 3T SYSTEM DISPLAYING MULTIPLE ERRORS ON PATIENT SIDE (E03, E07, E55, E58). THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF PATIENT/USER INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389941 ↗MalfunctionFeb 12, 2026No Flow
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT HEATER COOLER 3T SYSTEM SHOWED ERRORS PUMP 1 USES TOO MUCH POWER (E07) AND PUMP 1 WILL NOT START (E05). THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321208 ↗MalfunctionFeb 11, 2026Temperature Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315326 ↗MalfunctionJan 15, 2026Insufficient Cooling
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT HEATER COOLER 3T SYSTEM COOLING FUNCTION WAS NOT WORKING PROPERLY. THE ISSUE OCCURRED DURING PROCEDURE. THERE'S NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24077720 ↗
Other Controller, temperature, cardiopulmonary bypass devices
- CardioQuip Modular Cooler-Heater (MCH) MCH-1000(i)Cardioquip, LLC · Controller, Temperature, Cardiopulmonary Bypass2 recalls334 reports
- CardioQuip Modular Cooler-Heater (MCH) MCH-1000(m)Cardioquip, LLC · Controller, Temperature, Cardiopulmonary Bypass2 recalls206 reports
- Hemotherm 400CEGentherm Medical, LLC · Controller, Temperature, Cardiopulmonary Bypass1 recall30 reports
- Quantum QHC1Spectrum Medical Limited · Controller, Temperature, Cardiopulmonary Bypass54 reports
- Heater-Cooler System 3T 208V ~ / 60HzLivaNova Deutschland GmbH · Controller, temperature, cardiopulmonary bypass34 reports
- MPS 3 Delivery Set w/AA w/305cm Line (16C) 5163102Quest Medical Inc · Controller, Temperature, Cardiopulmonary Bypass3 reports
- MPS 3 Delivery Set w/AA w/106cm (16C) 5163103Quest Medical Inc · Controller, Temperature, Cardiopulmonary Bypass1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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