Avanos Recalls Cortrak2 Over Potential Enteral Tube Misplacement

This issue has led to 60 injuries, and 23 deaths.

This is an item classified as a Class I recall issued by FDA which is the most severe type. The devices could cause serious injuries, or even death.

Sam Brusco Associate Editor05.16.22

The FDA has identified Avanos Medical's recall of its Cortrak*2 useal access system. Cortrak 2 eternal access system Starting on March 21 the 21st of March, 2016, 629 devices were recalled across the U.S.

Cortrak*2 aids clinicians when placing medical feeding tubes into the stomach or small bowels of patients who need to be fed through the tube.

Avanos Medical The system's recall was caused by the deaths and injuries of patients resulting from misplacement of nasocentric/nasogastric tubes. Avanos Medical These tubes assist in insertion. If a nasogastric or nasoenteric tube is incorrectly inserted there could be damage to the vocal cords, lungs or trachea, which can result in serious injury or death.

According to Avanos the number of incidents has been a total of 60 injuries and 23 death in connection with this issue. There were several adverse events, including pneumothorax, respiratory failure, perforation, pneumonia and pleural effusion.

This recall is used to revise Cortrak*2's instructions for use, intended uses, and advise users to ensure that the tube is placed as per institutional guidelines prior to using the tube to deliver nutrients.

Clinicians are also advised to include the field correction notice about the issue to the operating manual and return the acknowledgement form included in the notice to Avanos. Avanos Medical feeding tube The users will shortly receive an update to the labeling and confirmation that the tubes were placed in accordance with institution policies.

Avanos Medical feeding tube