Terumo Cardiovascular System Corp
FDA adverse event reports naming Terumo Cardiovascular System Corp as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: TERUMO CARDIOVASCULAR SYSTEM CORP.
- Total reports
- 1,106
- Deaths
- 3
- Injuries
- 2
- Malfunctions
- 1,099
Reports per year
108
410
50911
30812
17713
7814
2915
Source: FDA adverse event reports by year received, 2008–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Console, Heart-Lung Machine, Cardiopulmonary BypassDTQ436
- Monitor, Blood-Gas, On-Line, Cardiopulmonary BypassDRY337
- Controller, Temperature, Cardiopulmonary BypassDWC134
- Blade, Saw, General & Plastic Surgery, SurgicalGFA62
- Control, Pump Speed, Cardiopulmonary BypassDWA46
- Generator, Pulsatile Flow, Cardiopulmonary BypassJOR31
- Sensor, Blood-Gas, In-Line, Cardiopulmonary BypassDTY19
- Pump, Blood, Cardiopulmonary Bypass, Roller TypeDWB13
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF12
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM10
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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