BEUDAMED
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    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.

    FDA Recall
    Terminated ·Pulsion Medical Inc·Product code KRB·November 4, 2014

    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.

    FDA Enforcement
    Class II ·Terminated·Pulsion Medical Inc·February 25, 2015

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·November 6, 2025

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·December 15, 2025

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·February 10, 2026