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

After seven years of failure for Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placing System has been recalled by the FDA has issued the most serious recall order.

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

Avanos started the recall earlier this year of the entire Cortrak*2 device that was used between January 2021 to Jan 2022. There were nearly 630 units originally distributed from April 2016 to the beginning.

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The safety event isn't an actual recall, but rather a meaning: Avanos does not ask healthcare providers to return the devices to the manufacturer. Avanos Mediacal Cortrak 2 Instead, it would like to make sure users are using the devices properly.

If a tube for feeding is not properly inserted it could cause damage to the vocal cords, lungs, or trachea and cause serious injury or death. Avanos Mediacal Cortrak 2 According to FDA, Avanos received reports of 23 deaths and 60 injuries since 2015, all of them related to FDA's use of the Cortrak*2 system to aid in the installation of a feeding tube.

Some of the injuries reported include respiratory failure, lung collapse, lung infections, and holes within the walls of the lungs and esophagus.

In the March 21 field correction notice, the Georgia-based company reminded users to "confirm the use of nasogastric or Nasoenteric tubes as per guidelines of the institution" according to the FDA. Avanos recommended that patients attach the safety notice and verify with Avanos they received the revised notice.

Avanos has announced that they will soon release a new label for the device. The labeling will contain the direction for mapping the tube's location, in accordance with their policies for their facilities.

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This is the second FDA warning regarding enteral feeding tubes this year. Avanos Medical In February, the agency released an safety announcement warning healthcare providers and parents of the risk of strangulation in children who use feeding tubes.

Two deaths in 2021 were reported to the notice. The notice was issued following two deaths in 2021. Avanos Medical In each case the tubing system was discovered to be placed around necks of patients who were under the age 2.

"The FDA believes that strangulation by enteral feed set tubing children is rare, however, healthcare professionals and caregivers have be aware that these incidents can occur," the agency stated in the announcement. This suggests that similar cases might not have been reported to FDA.


Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015