Notes

Avanos Medical faces Class I recall for feeding tube system implicated in 23 deaths in 2015

The FDA has issued its most severe warning in relation to the recall of Avanos Medical's feed tube enteral positioning system.

Cortrak*2 Enteral Access System contains an electromagnetic stylet , as well as an external receiver. The system, when used together will provide live footage of the medical feeding tube being placed in a patient's stomach.

Avanos Medical Avanos started a recall earlier in this year of the entire Cortrak*2 device used between Jan 2021 to Jan 2022. There were more than 630 units originally distributed from April 2016 through the beginning.

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The safety event is not a recall in its literal meaning: Avanos does not ask health professionals to return the devices to the manufacturer. Instead, it wants to make sure users are making use of the devices in a safe manner.

If a tube for feeding is not properly inserted, it can damage the vocal cords, lungs or the trachea and cause serious injury or death. Avanos recorded more than 23 deaths and 60 injuries in the last year, FDA declared. All of them were related to the FDA's Cortrak*2 system used to place a feeding tube.

Many different injuries have been reported such as respiratory failure (collapsed lung) lung infection, holes in the esophagus and walls.

According to FDA, Georgia-based company reminded users in its March 21 Field Correction Notice to "confirm placements of nasogastric & Nasoenteric tubes in accordance with institutional guidelines". Avanos also requested that users attach the safety notice and verify with Avanos they received the revised notice.

Avanos indicated that it will shortly issue new labels to the device. These will include the instructions for how to place a tube in line with their policies.

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This is the second FDA warning regarding tube feeding into the gastrointestinal tract this year. The FDA released a safety announcement in February warning parents and healthcare professionals of the risk of strangulation in the event that children are feeding tubes.

Cortrak 2 eternal access system Avanos Medical feeding tube Two deaths occurred in 2021 and were reported to the notice. In both instances, a tubing system was discovered be wrapped around the neck of a child under the age of two even though they were not being watched by the caregivers or hospital workers.

"While the FDA considers that strangulation caused by tubes for feeding tubes in the gastrointestinal tract of children is not likely to result in injuries or death, caregivers and healthcare providers should be aware of the potential risk," the FDA stated in its notice. The FDA also stated that similar incidents could not have been reported yet to the FDA.


Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause