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Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths since 2015

The FDA has given its most severe warning for the recall of Avanos Medical’s feed tube enteral positioning system.

Cortrak*2 Enteral Access System contains an electronic stylet, as well as an external receiver. When used together, the system gives a live stream of the medical feed tube being placed in the patient's stomach.

In spite of that goal however, the system has been linked to dozens of injuries to patients, causing Avanos to announce an recall in January of all Cortrak*2 devices between January 2021 and January 2022--totaling around 630 devices initially released between April 2016 and the beginning of the year.

The safety event isn't a recall in the literal sense of the word: Avanos is not asking healthcare professionals to send the devices back to the manufacturer, but rather to ensure they're using the devices correctly.

Avanos Medical feeding tube A tube for feeding that has not been properly inserted could cause serious injury and even cause death. Avanos has reported 23 deaths and 60 injury cases in 2015, according to FDA. All of this was due to the FDA's Cortrak*2 system, which directs placement of feeding tubes.

Avanos Medical There are many injuries reported, including respiratory failure, lung infection and collapsed lung.

In the March 21 field correction announcement, the Georgia-based firm advised users to "confirm the use of nasogastric or Nasoenteric tubes in accordance with guidelines of the institution" according to the FDA. Avanos requested that users attach the safety notification to the operating manual for the system and confirm that they have notified Avanos that the update was accepted.

https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Avanos said it would soon release updated labels to the device. These will include the instructions for where to place the tube in line the policies of Avanos.

Avanos Medical This marks the second warning the FDA has issued this year in relation to enteral feeding tubes. In February, the agency issued a safety message warning healthcare providers and parents of the possibility of strangulation when children are using feeding tubes.

Avanos Medical In the wake of two deaths in 2021, a notice was sent. In both instances, a tubing system was discovered to have inadvertently wrapped around the neck of a patient younger than 2 even though they were not being watched by the staff members or caregivers.

"While FDA believes strangulation of children with enteral feeding tubes in children is rare caregivers and healthcare professionals should be aware of the fact that these events could and do occur," the FDA said in the announcement. The FDA also suggested that the FDA has not yet received reports of similar cases.


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