Maquet Cardiopulmonary Gmbh
FDA adverse event reports naming Maquet Cardiopulmonary Gmbh as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MAQUET CARDIOPULMONARY GMBH.
- Total reports
- 4,380
- Deaths
- 341
- Injuries
- 177
- Malfunctions
- 3,862
Reports per year
Source: FDA adverse event reports by year received, 2014–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Console, Heart-Lung Machine, Cardiopulmonary BypassDTQ1,792
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM1,151
- Oxygenator, Cardiopulmonary BypassDTZ925
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF232
- Tubing, Pump, Cardiopulmonary BypassDWE137
- Controller, Temperature, Cardiopulmonary BypassDWC113
- Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI10
- Reservoir, Blood, Cardiopulmonary BypassDTN9
- Monitor, Blood-Gas, On-Line, Cardiopulmonary BypassDRY3
- System, Balloon, Intra-Aortic And ControlDSP2
Recent recalls
- 2026-02-05Open, ClassifiedUnder Investigation by firm
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
- 2025-07-29Open, ClassifiedUnder Investigation by firm
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Device does not comply with the labeling requirements of international standard IEC 60601-1.
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