Maquet Critical Care Ab
FDA adverse event reports naming Maquet Critical Care Ab as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MAQUET CRITICAL CARE AB.
- Total reports
- 20,987
- Deaths
- 176
- Injuries
- 820
- Malfunctions
- 19,951
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Ventilator, Continuous, Facility UseCBK17,770
- Gas-Machine, AnesthesiaBSZ1,436
- Compressor, Air, PortableBTI1,430
- Support, ArmIOY143
- Gastrointestinal Tubes With Enteral Specific ConnectorsPIF59
- Filter, Bacterial, Breathing-CircuitCAH41
- Sv70 VentilatorMNT41
- Console, Heart-Lung Machine, Cardiopulmonary BypassDTQ30
- Controller, Temperature, Cardiopulmonary BypassDWC12
- Mixer, Breathing Gases, Anesthesia InhalationBZR7
Recent recalls
- 2025-06-27Open, ClassifiedUnder Investigation by firm
Servo-u Ventilator System. Model Number: 6688600.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- 2025-06-27Open, ClassifiedUnder Investigation by firm
Servo-n Ventilator System. Model Number: 6694800.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- 2025-06-27Open, ClassifiedUnder Investigation by firm
Servo-u MR Ventilator System. Model Number: 6888800.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
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