January 17, 2018

FDA updates Safety Alert for Cortrak 2 Enteral Access System

By: Judy Mathias

Editor’s Note

The Food & Drug Administration (FDA) on January 12 updated a Safety Alert about pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems (Buffalo Grove, Illinois).

Several of the events were associated with cardiopulmonary arrest, and there were 11 reports of patient deaths. However, the relationship between the events and deaths cannot be concluded definitely in all cases.

EAS is designed to help in the placement of nasogastric feeding tubes by transmitting positional information via electromagnetic sensors to an external screen or console.



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