The Cortrak* 2 EAS device has been designed to help health care professionals to place the medical feeding tubes into the stomach or small bowel of patients who require nutrition through the tube
The FDA Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia)
The US Food and Drug Administration (FDA) has classified the recall of Avanos Medical’s Cortrak* 2 Enteral Access System (EAS) as a Class I recall.
According to the US regulator, a Class I recall is the most serious type among the three classes and the use of Class I recalled devices may cause serious injuries or death.
The medical technology company has designed the Cortrak* 2 EAS device to help health care professionals place the medical feeding tubes place into the stomach or small bowel of patients who require nutrition through the tube.
The system includes an electromagnetic stylet, an external receiver and a display monitor, and provides real-time information on the placement of the tube.
The wrong placement of nasogastric or nasoenteric tubes may damage a patient’s vocal cords, lungs or trachea, causing serious injuries or death, said FDA.
In March this year, Avanos recalled the Cortrak* 2 EAS based on reports of injuries and patient deaths due to nasoenteric or nasogastric tube misplacements.
The company has recalled a total of 629 devices that were distributed in the US, from 1 April 2016 till 1 January this year.
According to its recall communication, a total of 60 injuries and 23 patient deaths have been reported since 2015, due to misplacement of nasogastric feeding tubes using the Cortrak* 2 EAS.
Avanos Medical intends to update the device’s labelling, which requires the users to confirm the placement of nasogastric and nasoenteric tubes using Cortrak* 2 EAS.
The US FDA statement said: “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).”
In December last year, Avanos agreed to acquire OrthogenRx in a transaction valued at around $160m.