Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement

The FDA has identified Avanos Medical’s recall of its Cortrak*2 enteral access system. 629 devices distributed between 2016 and 2022 were recalled in the U.S., beginning on March 21.
 
Cortrak*2 helps clinicians place medical feeding tubes in the stomach or small bowel of patients needing to receive nutrition through the tube.
 
The system was recalled due to injury and patient death reports following nasocentric or nasogastric tube misplacement when the device is used to help place these tubes. If a nasogastric or nasoenteric tube is incorrectly inserted, damage can occur to the vocal cords, lungs, or trachea, resulting in serious injury or death.
 
According to Avanos’ safety communication, there have been 60 injuries and 23 deaths related to this issue. Adverse events reported included respiratory failure, pneumothorax, perforation, pneumonia, and pleural effusion.
 
The recall is being leveraged to update Cortrak*2’s instructions for use and intended uses, instructing users to confirm tube placement based on institutional protocols before using the tube to deliver nutrition.
 
Clinicians were also advised to attach the field correction notice about the issue to the operating manual and return the acknowledgement form included with the notice to Avanos. The company aims to soon provide users with updated labeling, including confirmation of tube placement according to institutional policies before use.