Probe, Thermodilution
FDA adverse event reports and recall history for probe, thermodilution (product code KRB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 370
- Deaths
- 5
- Injuries
- 50
- Malfunctions
- 311
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-02-17TerminatedPackaging
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
- TerminatedEquipment maintenance
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Potential for leakage due to defect in the thermoset check valve component.
- TerminatedEquipment maintenance
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Potential for leakage due to defect in the thermoset check valve component.
- TerminatedEquipment maintenance
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Potential for leakage due to defect in the thermoset check valve component.
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