CardioQuip Modular Cooler-Heater (MCH) MCH-1000(i)Recalls & reported problems

Cardioquip, LLC · The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This CardioQuip Modular Cooler-Heater controls the water temperature used during heart bypass surgery. Its 334 reports mostly describe microbial contamination of the device. The reports mention no deaths and no injuries. 2 recalls are open, over possible bacterial contamination that could infect patients and a heating chamber that could melt or burn its parts.

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: 334
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 334 adverse event reports that list this exact device (DI 00860000846103), received between Jul 15, 2023 and Sep 21, 2026 — classified as 334 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (332 reports).

2 FDA recall records name this device's identifier, 2 still open.

7 other recalls cover devices cleared under the same FDA submission (K102147); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Oct 24, 2023Class IIOpen, Classified
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Z-0565-2024 · Root cause: Process control · Recall details · FDA record ↗
Oct 19, 2023Class IIOpen, Classified
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Z-0439-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

Microbial Contamination of Device332
Contamination /Decontamination Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions333
Intraoperative Cardiac Valve Injury1

Recent adverse event reports

The 25 most recent of 334 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 21, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848531 ↗
MalfunctionSep 21, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848530 ↗
MalfunctionSep 21, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848529 ↗
MalfunctionSep 21, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848527 ↗
MalfunctionSep 21, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848526 ↗
MalfunctionSep 21, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848525 ↗
MalfunctionSep 17, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809888 ↗
MalfunctionSep 17, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809883 ↗
MalfunctionSep 8, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675039 ↗
MalfunctionSep 8, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675037 ↗
MalfunctionSep 8, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674954 ↗
MalfunctionJul 16, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841735 ↗
MalfunctionJul 16, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841734 ↗
MalfunctionJul 7, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON (B)(6) 2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25733070 ↗
MalfunctionJul 7, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 06/12/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25733062 ↗
MalfunctionJul 6, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON (B)(6) 2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725828 ↗
MalfunctionJun 29, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED HPC TESTING TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 06/09/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660645 ↗
MalfunctionJun 29, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 06/08/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652132 ↗
MalfunctionJun 29, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED HPC TESTING TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 06/09/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652130 ↗
MalfunctionJun 29, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 06/08/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652121 ↗
MalfunctionJun 29, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 06/08/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652120 ↗
MalfunctionJun 19, 2026Contamination /Decontamination Problem
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 05/27/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25561824 ↗
MalfunctionJun 3, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON (B)(6) 2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25383794 ↗
MalfunctionJun 3, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) TECHNICIAN NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION DURING AN ON-SITE INSPECTION AND SUBMITTED PICTURES TO CQ FOR REVIEW. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY REVIEWED THE PICTURES AND RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON 05/14/2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25383793 ↗
MalfunctionMay 28, 2026Microbial Contamination of Device
A CARDIOQUIP (CQ) CUSTOMER NOTIFIED CQ SERVICE THAT THE INTERNAL TUBING OF THIS DEVICE WAS SUSPECTED OF CONTAMINATION. THE CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGY RECOMMENDED THAT THE CUSTOMER PERFORM A QUARTERLY CLEANING AND DISINFECTION PROCEDURE ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). HPC TESTING IS ALSO RECOMMENDED TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. NO PATIENT INVOLVEMENT WAS REPORTED. HPC TEST RESULTS OUTSIDE OF CQ SPECIFICATIONS FOR WATER QUALITY WERE RECEIVED ON (B)(6) 2026, INDICATING DEVICE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25316423 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102147. One submission often covers many models, so check the product and lot details in each record.

Z-0566-2024 · Oct 24, 2023 · Open, Classified
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Z-0438-2024 · Oct 19, 2023 · Open, Classified
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Z-0069-2022 · Jun 24, 2021 · Open, Classified
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Z-0036-2022 · May 12, 2021 · Open, Classified
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Z-0037-2022 · May 12, 2021 · Open, Classified
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Z-0038-2022 · May 12, 2021 · Open, Classified
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Z-0035-2022 · May 12, 2021 · Open, Classified
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

Device details

UDI-DI	`00860000846103`
Brand	CardioQuip Modular Cooler-Heater (MCH)
Model	MCH-1000(i)
Company	Cardioquip, LLC
Product code	DWC · Controller, Temperature, Cardiopulmonary Bypass
Class	Class 2
FDA submission	K102147
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 16, 2020

Device type (GMDN): Cardiopulmonary bypass system heating/cooling unit

A mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way.

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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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