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 2015.

After seven years of failure in Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placement Systems was recalled. FDA has issued the most significant recall notice ever issued.

Avanos Medical feeding tube The Cortrak*2 Enteral Access System includes an electromagnetic stylet as well as an external receiver, and a display monitor. Cortrak 2 eternal access system When combined the system provides live video feeds of the placement of a medical feeding tube into the stomach of a patient, or in the small bowel, with an goal of improving the precision of the tube's tip positioning and reducing the risk of complications.

Despite this goal, however, the system has been implicated in numerous injuries to patients, leading Avanos to issue a recall in January of all Cortrak*2 units used between January 2021 and January 2022--totaling around 630 devices initially released between April 2016 and the start of this year.

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The incident of safety isn't a recall. Avanos doesn't ask healthcare providers send the devices back, but to ensure that they use them properly.

https://www.hcplive.com/view/fda-issues-letter-to-health-care-providers-about-pneumothorax-events An incorrectly placed feeding tube can damage vocal cords and lungs. It can also result in severe injury or death. According to the FDA, Avanos received reports of 23 deaths and 60 injuries since 2015, all of which were related to the FDA's usage of the Cortrak*2 system to aid in the placement of the feeding tube.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview There are a variety of injuries that have been reported, including respiratory failure, collapsed lung, and lung infections.

In its March 21 field correction announcement, the Georgia-based firm warned users to "confirm the use of nasogastric or nasoenteric tubes according to the policies of the institution," according to the FDA. Avanos asked users to add the safety announcement to the operation manual of the system and then confirm that they have notified Avanos that the change was approved.

feeding tube placement Avanos announced that they'll soon release new labeling on the device. The label will contain the directions to put tubes according to their guidelines.

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The FDA has issued a second warning regarding enteral feeding tube use. In February, the FDA released a safety announcement to inform healthcare professionals and parents about the danger of strangulation for children using tubes for feeding.

In the wake of two deaths in 2021, the notice was sent. Each time the notice was followed by two deaths in 2021.

"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 such events are possible and can happen," the agency said in the announcement and suggested that similar cases may not yet have been reported to the FDA.

Avanos Medical
Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/