Avanos Medical faces Class I recall because of the feeding tube system's connection to 23 deaths.

The FDA has issued the most severe of warnings for the recall of Avanos Medical’s feed tube enteral positioning system.

Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. The system provides a live feed of medical tubes being placed into the stomachs of patients or small bowels. This allows for improvement of tip placement accuracy and reduces the risk of complications.

https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Avanos was not pleased with its mission and launched an recall of all Cortrak*2 units between January 2021 and January 2022. The recall included nearly 630 devices distributed in total between April 2016 & the beginning this year.

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical RELATED
A tiny gadget can create chaos for tube feeders
The safety incident isn't a recall in the strict sense: Avanos is not asking health professionals to return the devices back to the manufacturer, but to ensure that they're using them correctly.

A feeding tube that is not correctly placed can result in severe injury or even death. Avanos has reported the deaths of 23 people and 60 injuries cases in 2015 according to the FDA. This was all due to FDA's Cortrak*2 system that guides the how to insert feeding tubes.

There are many injuries that have been reported, such as respiratory failure, collapsed lung and lung infections.

In its March 21 field correction notice, the Georgia-based company reminded users to "confirm the placement of nasogastric as well as Nasoenteric tubes as per guidelines of the institution" according to the FDA. They're also required to add the safety note to the system's operating manual and verify with Avanos that they've received the update.

Avanos has announced that they will soon issue updated labels for the device.  https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause They will contain the instructions for how to place a tube, in accordance with their guidelines.

RELATED
FDA proposes order forcing Philips to fix or replace or reimburse all ventilators that have been recalled.
Avanos Mediacal Cortrak 2 This is the second caution that the FDA has issued in the past year in regards to the use of enteral feeding tubes. In February, the FDA issued the safety communication informing parents and healthcare professionals about the risk of strangulation due to the use of feeding tubes for children.

Two deaths in 2021 were disclosed to the notice.  https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ In each instance the tubing system was discovered to be wrapped around the neck of a child under the age of two while they weren't being directly observed by their medical staff or caregivers.

"The FDA believes that strangulation with enteral feed set tubing children is rare, however, healthcare providers and caregivers need to be aware that such instances can occur and can happen," the agency stated in its notice. This suggests that similar cases might not have been reported to FDA.