Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
FDA adverse event reports and recall history for sensor, blood-gas, in-line, cardiopulmonary bypass (product code DTY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 341
- Deaths
- 0
- Injuries
- 0
- Malfunctions
- 341
Reports per year
Source: FDA adverse event reports by year received, 1997–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-04-11TerminatedDevice Design
Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
- 2011-04-11TerminatedDevice Design
Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
Monitor sensor, blood-gas, in-line, cardiopulmonary bypass 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.