Notes

Avanos Medical faces Class I recalls for its feeding tube system that has been linked to 23 deaths in the last year.

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

The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a monitor for display. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 The system provides a live stream of medical tube feeding that are inserted into patients' stomachs or small bowels. This allows for improvement of tip placement accuracy and reduces the risk of complications.

Despite that mission, it has been implicated in numerous injuries to patients which led Avanos to issue a recall in January of all Cortrak*2 devices used between January 2021 and January 2022, totalling more than 630 devices that were distributed between April 2016 and the beginning of this year.

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The safety incident does not constitute a recall. Avanos has asked healthcare providers to not send the devices back at the request of the manufacturer. However, they want to make sure they are using the devices.

An incorrectly placed feeding tube could cause damage to vocal cords and lungs. It could also cause serious injury or even death. Avanos has reported more than 60 injury cases in 2015, according to FDA. This was all due to FDA's Cortrak*2 system, which guides placement of feeding tubes.

The most common injuries are respiratory failure as well as lung infections, collapsed lung, pleural effusion, and holes in the walls of the lungs, esophagus and bowel.

feeding tube placement According to FDA the Georgia-based company advised users in the March 21 Field Correction Notice to "confirm placements of nasogastric & Nasoenteric tubes as per the policies of the institution". Avanos recommended that patients be sure to attach the safety announcement and confirm with Avanos that they have received the latest version.

Avanos Medical Avanos Medical Avanos announced that it will soon release a revised labeling for its device. This will include directions to indicate the location of a tube in accordance to their policies for their facility.

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This is the FDA's third caution regarding the use of an enteral tube for feeding use. In February, the FDA released an safety announcement informing healthcare professionals and parents of the possibility of strangulation for children using feeding tubes.

After two deaths that occurred in 2021, a notice was sent. feeding tube placement Each time the notice was followed by two deaths in 2021.

"While the FDA believes that the risk of serious injury or death caused by strangulation from tubing for feeding through the enteral system in children is uncommon healthcare professionals and their caregivers must be aware that such events can and do occur," the agency said in its notice and suggested that similar incidents may not have been reported to the FDA.


Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement