Notes

Avanos Medical is facing a Class I recall due to problems with the feeding tube system that have caused 23 deaths since the year 2015.

After seven years in which Avanos Medical's enteral tube placement system was plagued with unfortunate luck and a lack of trust, the FDA has issued its most severe instruction to recall the product.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a monitor for display. The system, when used together with the display monitor, allows live video of the medical tube that is placed inside the stomach of a patient.

Avanos was not pleased with the results and announced an recall of all Cortrak*2 units between January 2021 & January 2022. Avanos Medical The recall included nearly 630 devices distributed in total between April 2016 & the start of this year.

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The safety event is not considered to be an recall. Avanos has asked healthcare providers to not send the devices back to the expense of the manufacturer. However, they want to ensure they are correctly making use of the devices.

feeding tube placement The incorrect placement of the feeding tube incorrectly can cause damage to vocal cords or lungs. Avanos has reported the deaths of 23 people and 60 injuries cases since 2015, according to FDA. All of this was due to the FDA's Cortrak*2 system, which guides placement of feeding tubes.

These injuries may be caused by respiratory failure, collapsed lungs, lung infections, pleural effusion and holes in the walls lungs as well as the esophagus and bowel.

Avanos Mediacal Cortrak 2 According to FDA the Georgia-based company reminded users in its March 21 Field Correction Notification to "confirm placements of nasogastric & nasoenteric tubes according to the policies of the institution". https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos Medical Avanos has also asked users to add the safety notice to the operating guideline of the system and confirm that they have received the latest update.

Avanos stated that it will shortly issue a revised labeling for its product. This will include directions to map the placement of the tube according to the policies of their facility.

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This is the FDA’s second warning on tube feeding into the gastrointestinal tract this year. In February the FDA issued a safety alert to parents and healthcare providers regarding the dangers of strangulation for children using feeding tubes.

The announcement came in the wake of two reports of deaths in 2021. In both cases the tubing system was accidentally placed around the neck of a child when they weren't being closely watched by caregivers or hospital staff.

"While the FDA believes that strangulation from tubing for the feeding tube in children is not likely to result in fatal injury or death caregivers and healthcare professionals should be aware of the potential risk," the FDA stated in the announcement. It also noted that similar cases may not have been reported to the FDA.


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