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Avanos Medical faces a Class I recall over feeding tube system connected to 23 deaths in 2015

After seven years of poor luck with Avanos Medical’s insertal feeding tube placement system for children The FDA has issued its most serious warning about the recall of this device.

Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. Avanos Medical When they are used together the system provides live video feeds of the process of inserting an medical tube for feeding into a patient's stomach or small bowel, with the intention of improving the accuracy of the tube's tip placement and reducing complications.

Avanos Medical Avanos began an earlier this year of all Cortrak*2 equipment in use between Jan 2021 to Jan 2022. There were nearly 630 units distributed between April 2016 through the beginning.

The safety incident isn't a recall in its literal meaning: Avanos does not ask medical professionals to return devices back to the manufacturers. Instead, it would like to make sure they are making use of the devices properly.

Avanos Medical feeding tube If a feeding tube is not properly installed, it may harm the vocal cords, lungs, or trachea, potentially leading to grave injury or even death. Avanos was notified of more than 60 injuries and 23 deaths in the year 2015 by the FDA. Cortrak 2 eternal access system The incidents were all related to the Cortrak*2 system, which guides the placement of the feeding tube.

These injuries could include respiratory failure, collapsed lungs lung infections, and holes within the lung's walls and esophagus.

The FDA reminded users of the need to verify placement of nasogastric or nasoenteric tube in accordance with their institution policies in the March 21 field correction notification. They've also been asked to add the safety note to the system's operating manual and confirm with Avanos that they received the latest version of the notice.

Avanos announced that it will shortly issue a revised labeling for its product. https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ It will also include instructions to indicate the location of a tube in accordance to their facility's policies.

This marks the second warning the FDA has issued this year with regard to enteral feeding tubes. The FDA released a safety announcement in February warning parents, healthcare providers and children about the possibility of strangulation through tubes for feeding.

Cortrak 2 eternal access system Two deaths in 2021 were reported in the announcement. In both cases, a tubing device was found to be wrapped around the neck of a patient who was less than two years old while they were not being watched by caregivers or hospital workers.

"While the FDA believes that serious injury or death from strangulation with tubing for feeding through the enteral system in children is rare Healthcare providers and their caregivers need to be aware that such events are possible and can happen," the agency said in the notice, suggesting that other similar cases may not yet have been reported to the FDA.


Website: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/