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
- 21,095
- Deaths
- 180
- Injuries
- 826
- Malfunctions
- 20,049
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Ventilator, Continuous, Facility UseCBK17,854
- Gas-Machine, AnesthesiaBSZ1,451
- Compressor, Air, PortableBTI1,430
- Support, ArmIOY143
- Gastrointestinal Tubes With Enteral Specific ConnectorsPIF60
- Sv70 VentilatorMNT45
- Filter, Bacterial, Breathing-CircuitCAH41
- Console, Heart-Lung Machine, Cardiopulmonary BypassDTQ30
- Controller, Temperature, Cardiopulmonary BypassDWC12
- Mixer, Breathing Gases, Anesthesia InhalationBZR7
Recent recalls
- 2026-08-14Open, ClassifiedUnder Investigation by firm
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
- 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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