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Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths in the last year.

Seven years after bad luck for the Avanos Medical enteral feeding tube system The FDA has issued its most severe designation for a recall of the device.

Avanos Mediacal Cortrak 2 Cortrak*2 Enteral Access System features an electromagnetic stylet with an external receiver as well as an LCD monitor. It can be used in conjunction to show a live stream which shows the process of inserting a feeding tube in the stomach of the patient. This procedure is carried out in the hope of increasing precision and reducing the risk of complications.

Avanos issued the recall earlier in the month of all Cortrak*2 device in use between January 20,21 and January 20,22. Avanos Medical Avanos Mediacal Cortrak 2 Avanos Medical The recall affected nearly 630 devices.

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The safety incident doesn't count as a recall in any strict sense. Avanos isn't asking healthcare providers for the device to be returned to the manufacturer. It's merely to ensure that they're using it correctly.

If a feeding tube is incorrectly inserted it could cause damage to the vocal cords, lungs or the trachea and cause grave injury or even death. Avanos was alerted of more than 60 injuries and 23 deaths in the year 2015 by the FDA. feeding tube placement The incidents were all connected to the Cortrak*2 system that guides the placement of feed tubes.

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

The FDA advised users that they need to confirm the the placement of a nasogastric or nasoente tube in accordance with their institution policies in its March 21 field correction notice. Avanos has asked patients to include a safety note in their operating manuals and verify they have been updated.

Avanos stated that it will shortly issue a revised labeling for its device. It will also include instructions for locating the position of the tube according to the policies of their facility.

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This is the FDA's second caution regarding the use of an enteral tube for feeding use. In February, the FDA released an safety communication that warned parents and health professionals about the risk of strangulation due to the use of feeding tubes by children.

feeding tube placement The notice followed two reports of deaths in 2021. In both instances, a tubing system was wrapped around a child's neck while they were not being closely observed by the hospital staff or caregivers.

"While the FDA believes that the risk of serious injury or death due to strangulation caused by enteral feeding tubing in children is uncommon, healthcare providers and their caregivers must be aware of the fact that these incidents could and do happen," the agency said in its notice, suggesting that other similar incidents may not have been reported to the FDA.


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