Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have resulted in 23 deaths since 2015.

Seven years after unlucky luck for Avanos Medical's feed tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has issued the most serious of designations for recalls of the product.

Cortrak*2 Enteral Access System features an electromagnetic stylet with an external receiver as well as an LCD monitor. When used together it provides live video feeds of the positioning of medical-grade feeding tubes into the stomach of a patient or into their small bowel, with the intention of improving the accuracy of the tube's tip positioning and reducing the risk of complications.

Despite that mission, however, the system has been implicated in many injuries sustained by patients, leading Avanos to launch a recall in January of all Cortrak*2 devices used between January 2021 to January 2022. This totals nearly 630 devices first distributed between April 2016 and the start of this year.

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The safety incident isn't a recall in the literal sense: Avanos is not asking health professionals to return the devices back to the manufacturer but to ensure that they're using them correctly.

The incorrect placement of a feeding tube could cause injury to the vocal cords, lungs or the trachea. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical This could result in serious injury, or even death. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Avanos was alerted of more than 60 injuries and 23 deaths in 2015 by the FDA. The incidents were all connected to the Cortrak*2 system that controls the position of feed tubes.

Avanos Medical feeding tube Cortrak 2 eternal access system The most common injuries are respiratory failure, collapsed lung, lung infection the pleural effusion and holes in the lung's walls or esophagus, as well as the bowel.

According to FDA the Georgia-based firm advised users in the March 21 Field Correction Notification to "confirm the use of nasogastric tubes and nasoenteric tubes according to institutional guidelines". Avanos is also asking them to attach the safety note to the operating guideline of the system and confirm that they've received the updated.

Avanos has indicated that it will soon issue new labeling for its device. The labeling will contain the direction to map the tube's location, in accordance with their policies for their facilities.

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The FDA has issued a second warning this year regarding tube feeding through the stomach. In February, the agency issued a safety communication warning healthcare providers and parents about the danger of strangulation when children use feeding tubes.

After two deaths in 2021, this notice was released. The notice came in the wake of two deaths in 2021. In each case the tubing system was found to be wrapped around the necks of patients younger than age 2.

"While the FDA believes that strangulation from enteral feeding tube tubing in children is unlikely to cause death or serious injury, caregivers and healthcare providers should be aware of this potential risk," the FDA stated in its notice. It also noted that other similar cases might not have been reported yet to the FDA.


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