Heater-Cooler System 3T 208V ~ / 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
Quick summary
This LivaNova Heater-Cooler System 3T is a temperature controller used during cardiopulmonary bypass, which warms or cools the patient's blood as it circulates. The 33 reports mostly describe microbial contamination of the device, pumping problems, and fluid or blood leaks, along with incorrect display messages and temperature problems. No deaths and no injuries are mentioned in the reports. There are no recalls naming this device.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04033817900511), received between Mar 7, 2017 and Sep 21, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (11 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.
Reports received per month
Most reported problems
Device problems
- Microbial Contamination of Device11
- Pumping Problem7
- Fluid/Blood Leak4
- Device Displays Incorrect Message3
- Leak/Splash3
- Temperature Problem3
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Cooling2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Patient Involvement5
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Pumping Problem
LivaNova Deutschland received a report of a 3T Heater/Cooler for which the patient pump was found to not work properly. The issue was highlighted during a service intervention. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835487 ↗MalfunctionJul 9, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25762677 ↗MalfunctionNov 21, 2025Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE HEATER COOLER 3T SYSTEM HAS TESTED POSITIVE FOR MNT CHIMERA. THERE IS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23618877 ↗MalfunctionOct 31, 2025Temperature Problem; Temperature Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433997 ↗MalfunctionJul 29, 2025Unexpected Shutdown; Unexpected Shutdown
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646245 ↗MalfunctionJul 11, 2025Pumping Problem; Pumping Problem
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT OF A NOT FUNCTIONING PATIENT PUMP 1 IN A 3T HEATER COOLER. THE CUSTOMER INSTALLED A NEW PATIENT PUMP AND THE NEW PUMP IS MAKING NOISE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22477795 ↗MalfunctionJul 10, 2024Temperature Problem; Temperature Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19708379 ↗MalfunctionOct 12, 2023Fluid/Blood Leak; Leak/Splash; Pumping Problem; Fluid/Blood Leak; Leak/Splash; Pumping Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17921219 ↗MalfunctionJul 11, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17297919 ↗MalfunctionJun 5, 2023Pumping Problem; Pumping Problem
MalfunctionApr 17, 2023Pumping Stopped; Pumping Stopped
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16750545 ↗MalfunctionApr 11, 2023Pumping Problem; Temperature Problem; Pumping Problem; Temperature Problem
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT A 3T HEATER COOLER PRESENTED DISPLAYED AN ERROR RELATED TO BLOCKED OR TOO SLOW PUMP (EE7) ON PATIENT SIDE DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16711473 ↗MalfunctionApr 3, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT OF WATER LEAKING FROM A 3T HEATER COOLER DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663445 ↗MalfunctionMar 29, 2023Pumping Problem; Pumping Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16636423 ↗MalfunctionOct 7, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA. REPORTEDLY, THE EQUIPMENT WAS NEVER PLACED IN THE OR, WEEKLY CHANGE OF WATER WAS DONE AND DISINFECTION WITH MINNCARE WAS DONE EVERY 2 WEEKS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15560537 ↗MalfunctionJul 21, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA RECEIVED REPORT OF HEATER COOLER 3T SYSTEM FOUND CONTAMINATED WITH NTM. THE TYPE OF BACTERIUM WAS NO SPECIFIED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15072577 ↗MalfunctionJul 21, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA RECEIVED REPORT OF HEATER COOLER 3T SYSTEM FOUND CONTAMINATED WITH NTM. THE TYPE OF BACTERIUM WAS NO SPECIFIED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15072567 ↗MalfunctionJul 21, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA RECEIVED REPORT OF HEATER COOLER 3T SYSTEM FOUND CONTAMINATED WITH NTM. THE TYPE OF BACTERIUM WAS NO SPECIFIED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15072558 ↗MalfunctionMay 24, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED. THE TYPE OF BACTERIUM WAS NOT SPECIFIED BY THE CUSTOMER. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14486013 ↗MalfunctionApr 28, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA (B)(4) RECEIVED A REPORT THAT, THE LABORATORY OF (B)(6) 2020 SHOW CONTAMINATION WITH NTM CHIMERA. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14237433 ↗MalfunctionApr 20, 2022Degraded; Degraded
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T HAD A DEFECTIVE COOLING COMPRESSOR. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14155364 ↗MalfunctionApr 15, 2022Insufficient Cooling; Insufficient Cooling
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T HAD A DEFECTIVE COOLING COMPRESSOR. THE ISSUE WAS IDENTIFIED BY THE CUSTOMER DURING ROUTINE MAINTENANCE.THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14117005 ↗MalfunctionApr 1, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHELONAE IN (B)(6) 2021. THERE IS NO KNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13974385 ↗MalfunctionApr 1, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T WAS FOUND TO BE CONTAMINATED WITH MOLD LIKE FUNGUS (TMTC). THERE IS NO KNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13974362 ↗MalfunctionApr 1, 2022Microbial Contamination of Device; Microbial Contamination of Device
LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHELONAE IN (B)(6) 2020. THERE IS NO KNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13974314 ↗
Other Controller, temperature, cardiopulmonary bypass devices
- CardioQuip Modular Cooler-Heater (MCH) MCH-1000(i)Cardioquip, LLC · Controller, Temperature, Cardiopulmonary Bypass2 recalls334 reports
- Heater-Cooler System 3T 120V ~ / 60HzLivaNova Deutschland GmbH · Controller, temperature, cardiopulmonary bypass1 recall8 deaths277 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
- 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
- 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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