Notes

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

After seven years of bad luck with Avanos Medical's insertal feeding tube placement system for children, the FDA has issued the most severe warning about the recall of this device.

Cortrak*2 Enteral Access System contains an electromagnetic stylet , as well as an external receiver. Avanos Mediacal Cortrak 2 The system can be used in conjunction to provide a live feed that shows the procedure of inserting a feeding tube in the stomach of an individual. This is done in the hope of increasing accuracy and reducing complications.

Avanos launched a recall earlier in the year to all Cortrak*2 devices which were in use between January 2021 and January 2022. This totaled nearly 630 devices. The devices were distributed in the first time from April 2016 and the beginning of the year.

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The safety incident is not a recall in its literal sense: Avanos does not ask health professionals to return the devices to the manufacturer. Instead, it would like to ensure that users are using the devices properly.

If a feeding tube is not properly inserted it could cause damage to the vocal cords, lungs, or trachea, potentially leading to serious injury or death. Avanos Medical Avanos reported the number of injuries to patients and deaths to patients in 2015, the FDA stated. feeding tube placement All of these were directly related to FDA's Cortrak*2 system that is used to insert a feeding tube.

Numerous injuries have been documented, including respiratory failure (collapsed lung) lung infection, holes in the esophagus's walls.

The FDA reminded 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 asked users to attach the safety notification to the system's operation manual and confirm that they have notified Avanos that the update was accepted.

Avanos Mediacal Cortrak 2 Avanos has indicated that it will soon issue a new label for its device. The labeling will contain the direction to map a tube's location in accordance their facility policies.

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This is the FDA's second warning this year regarding tube feeding through the stomach. In February, the FDA issued an safety alert to parents and healthcare providers regarding the dangers of strangulation for children who use feeding tubes.

This announcement was made in response to two deaths in 2021. Avanos Mediacal Cortrak 2 The notice followed two reports of deaths in 2021. In each instance the tubing system was found to be placed around necks of patients younger than age 2.

"While the FDA believes that death or serious injury caused by strangulation from enteral feeding set tubing for children is extremely rare healthcare professionals and caregivers should be aware that these events can and do occur," the agency said in the notice, suggesting that other similar incidents may not have been reported 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