FDA Class I Recall: Cortrak*2 Enteral Access System by Avanos Medical

May 16, 2022

The U.S. Federal Drug Administration (FDA) has announced that Avanos Medical is recalling the Cortrak*2 Enteral Access System. The recall is the result of reports of injuries and patient deaths after nasoenteric or nasogastric tubes have been misplaced when this device is used to help with their placement.

According to Avanos Medical's recall communication, there have been 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the CORTRAK* 2 Enteral Access System, since 2015. Adverse events reported included respiratory failure, pneumothorax (collapsed lung), perforation (a hole in the wall of the lung, esophagus, or bowel), pneumonia (a lung infection), and pleural effusion (excess fluid in the space between the lungs and the chest cavity).

This recall is being used to make updates to the device's labeling, including the instructions for use and intended uses. The updates instruct users to confirm tube placement based on their institution's protocols before using the tube to deliver nutrition.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

If a nasogastric or nasoenteric tube is inserted incorrectly, patients could experience damage to the vocal cords, lungs, or trachea, all of which can lead to serious injury or death.

The Avanos Medical CORTRAK 2 Enteral Access System is designed to help trained healthcare personnel place medical feeding tubes into the stomach or small bowel of patients who need to receive nutrition through the tube.

On March 21, 2022, Avanos Medical issued a field correction notice to its customers who used these devices between January 2021 and January 2022.

The notice included the following instructions:

  • Confirm placement of nasogastric and nasoenteric tubes according to institutional policies.
  • Attach the field correction notice about the issue to the operator's manual.
  • Return the acknowledgement form included with the emailed notice to Avanos Medical.

In the near future, Avanos Medical intends to provide users with updated labeling, including the step for users to confirm placement of nasogastric and nasoenteric tubes according to institutional policies before use. Customers will need to return another acknowledgement form after they received the updated information.

FDA release 

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