Swan-Ganz thermodilution catheters manufactured between December 26, 2017, and April 19, 2018, are being recalled by Edwards Lifesciences, according to the US Food and Drug Administration (FDA).
The class I recall is being initiated because of incorrect assembly leading to catheter tube (lumens) reversal. If the lumens are reversed, inaccurate pulmonary artery and central venous pressure values and waveforms may result, leading to unintended treatment.
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