February 14, 2019

FDA: Class I recall of Edwards Lifesciences Swan-Ganz Thermodilution Catheter

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on February 5 identified the recall by Edwards Lifesciences (Irvine, California) of its Swan-Ganz Thermodilution Catheter as Class I, the most serious.

The recall was initiated because of incorrect assembly and reversal of catheter lumens that can expose the patient to serious adverse health consequences or death.

The recalled catheters−131F7, 131F7J, 131F7P, 131VF7P, 151F7−were manufactured between December 26, 2017 and April 19, 2018, and distributed from January 20, 2018 to August 20, 2018.

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