FDA updates Safety Alert for Cortrak 2 Enteral Access System

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.

Posted 01/12/2018] This letter corrects the previously issued Dear Health Care Provider Letter from January 11, 2018 AUDIENCE: Surgery, Critical Care Medicine ISSUE: The FDA is providing information about reports of pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems. Most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement.

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