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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This issue is responsible for at the very least 60 injuries and 23 fatalities.

feeding tube placement This recall has been classified by FDA as a class I recall. This is the most serious type. Avanos Mediacal Cortrak 2 Use of these devices may result in serious injuries or even death.

Sam Brusco Associate Editor05.16.22

The FDA has discovered the recall by Avanos Medical of their Cortrak*2 entry access system. 629 devices, which were distributed between 2016 - 2022, were recalled by the U.S. starting on March 21.

Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system Cortrak*2 assists clinicians in placing medical feeding tubes in the stomach or small bowels of patients who require to be fed through the tube.

The system was recalled because of injuries and death reports resulting from nasocentric and Nasogastric tube misplacement while it is employed to to insert these tubes. Nasogastric, also known as nasoenteric, tube that is not correctly inserted could result in damage to the vocal cords or the trachea. This can lead to serious injuries, or death.

According to Avanosthe safety announcement there were 60 deaths and 23 injuries resulting from the issue. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The adverse events that were identified included perforation, respiratory failure, and pneumonia, in addition to the pleural effusion.

This recall is used to update Cortrak*2’s instructions on use, intended use and also remind users to verify tube placement in accordance with institutional guidelines prior to using the tube to deliver nutrition.

Clinicians were advised to attach the corrective notice for field use regarding the issue to their operating manual and to return the acknowledgment form that was included with the notice to Avanos. The company is expected to be able to send out updated labeling for users, which will include confirmation of the placement of tubes according to the policies of the institution.


My Website: https://prais.paho.org/es/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm/