Maquet Cardiopulmonary Ag
FDA adverse event reports naming Maquet Cardiopulmonary Ag as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MAQUET CARDIOPULMONARY AG.
- Total reports
- 4,249
- Deaths
- 202
- Injuries
- 1,044
- Malfunctions
- 2,971
Reports per year
Source: FDA adverse event reports by year received, 2008–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Console, Heart-Lung Machine, Cardiopulmonary BypassDTQ1,266
- Oxygenator, Cardiopulmonary BypassDTZ1,117
- Controller, Temperature, Cardiopulmonary BypassDWC655
- Tubing, Pump, Cardiopulmonary BypassDWE364
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM333
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF191
- Filter, Blood, Cardiopulmonary Bypass, Arterial LineDTM142
- Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI56
- Reservoir, Blood, Cardiopulmonary BypassDTN48
- Heat-Exchanger, Cardiopulmonary BypassDTR32
Recent recalls
- 2025-05-27Open, ClassifiedUnder Investigation by firm
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
- TerminatedDevice Design
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
- TerminatedComponent design/selection
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
- TerminatedComponent design/selection
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
- TerminatedComponent design/selection
Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
Monitor Maquet Cardiopulmonary Ag automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.