Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have led to the deaths of 23 patients since the year 2015.

Seven years after bad experience with Avanos Medical's feeding tube placement system for children The FDA has issued its most serious warning about the recall of this device.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a monitor for display. Avanos Mediacal Cortrak 2 The system provides a live feed of medical tubes being placed in patients' stomachs or small bowels. This permits the improvement of tip placement accuracy and the elimination of any complications.

Despite that goal however, the system has been implicated in the occurrence of dozens of patient injuries which led Avanos to launch a recall earlier this year of all Cortrak*2 units used between January 2021 to January 2022. This totals more than 630 devices that were released between April 2016 until the beginning of the year.

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https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The safety event is not a reason to issue the occurrence of a recall. Avanos has asked healthcare providers not to send the devices back to the expense of the manufacturer. But, they would like to make sure they are using the devices.

Incorrectly inserting a feeding tube could result in damage to the vocal cords, lungs, or the trachea. This could lead to serious injuries, or death. Avanos was informed of 23 deaths and 60 injuries in the year 2015 by the FDA. These incidents were all connected to the Cortrak*2 system that controls the position of a feed tube.

There are several injuries that have been reported, like respiratory failure, collapsed lung, lung infections.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 According to FDA, the Georgia-based company issued a field correction note reminding users to confirm the position of nasogastric and tubs for nasoenteric according to the institution's policies. Avanos also requested that users include the safety warning and confirm with Avanos they received the updated.

Avanos has announced that they will shortly issue new labels to the device. They will contain instructions on where to put the tube in line with their guidelines.

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The FDA has issued a second caution regarding the use of an enteral tube for feeding use. The FDA released the safety message in February, warning parents and healthcare professionals of the danger of strangulation if children are feeding through tubes.

Two deaths in 2021 were reported in the announcement. A tubing system was not closely monitored by the staff or caregivers wrapped around the necks and necks of children under two years of age.

"While the FDA considers that strangulation caused by tubing for the feeding tube in children is not likely to result in injuries or death caregivers and healthcare professionals should be aware of the potential risk," the FDA stated in the notice. It also noted that similar incidents could not have been reported yet to the FDA.

feeding tube placement
My Website: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical