After seven years of bad luck for Avanos Medical’s enteral feeding tube placement system, the FDA has handed down its most serious designation for a recall of the device.
The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a display monitor. When used together, the system offers a live feed of the placement of a medical feeding tube into a patient’s stomach or small bowel, with an aim of improving the accuracy of the tube's tip placement and reducing complications.
In spite of that mission, however, the system has been linked to dozens of patient injuries, leading Avanos to launch a recall earlier this year of all Cortrak*2 devices used between January 2021 and January 2022—totaling nearly 630 devices first distributed between April 2016 and the beginning of this year.
The safety event isn’t a recall in the literal sense of the word: Avanos is not asking healthcare providers to send the devices back to the manufacturer, but rather to ensure they’re using them correctly.
If a feeding tube is incorrectly inserted, it can damage the vocal cords, lungs or trachea, potentially leading to serious injury or death. Indeed, Avanos has received reports of 23 deaths and 60 injuries since 2015, the FDA said, all of which were linked to the use of the Cortrak*2 system to guide the placement of a feeding tube.
The reported injuries include respiratory failure, collapsed lung, lung infection, pleural effusion, and holes in the walls of the lungs, esophagus and bowel.
In its March 21 field correction notice, the Georgia-based company reminded users to “confirm placement of nasogastric and nasoenteric tubes according to institutional policies,” per the FDA. They’ve also been asked to attach the safety notice to the system’s operating manual and confirm with Avanos that they received the update.
Avanos said it will soon issue updated labeling for the device that will include the direction to map out a tube’s placement in accordance with their facility’s policies before using the system to help install the tube.
This marks the second warning the FDA has issued this year with regard to enteral feeding tubes. In February, the agency put out a safety communication warning healthcare providers and parents of the risk of strangulation when children use feeding tubes.
The notice followed two reports of death in 2021. In each instance, a tubing system was found to have inadvertently wrapped around the neck of a patient under the age of two while they weren’t being directly monitored by caregivers or hospital workers.
“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, healthcare providers and caregivers should be aware that these events can and do occur,” the agency said in the notice, suggesting that other similar cases may not yet have been reported to the FDA.