Cardioquip, LLC
FDA adverse event reports naming Cardioquip, LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CARDIOQUIP, LLC.
- Total reports
- 1,295
- Deaths
- 6
- Injuries
- 13
- Malfunctions
- 1,276
Reports per year
Source: FDA adverse event reports by year received, 2017–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2023-12-15Open, ClassifiedProcess control
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- 2023-12-15Open, ClassifiedProcess control
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- 2023-12-01Open, ClassifiedDevice Design
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- 2023-12-01Open, ClassifiedDevice Design
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-06Open, ClassifiedError in labeling
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- Open, ClassifiedUnder Investigation by firm
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
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