Notes

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

Seven years after bad luck for the Avanos Medical enteral feeding tube system, the FDA has handed down its most severe designation for recalls of the device.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as a monitor for display. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical When combined it provides an live stream of the placement of medical-grade feeding tubes into the stomach of a patient, or in the small bowel, with the goal of improving the precision of the tube's placement and reducing complications.

Avanos Medical feeding tube Avanos was not satisfied with the results and announced a recall of all Cortrak*2 units between January 2021 and January 2022. The recall covered more than 630 units that were distributed between April 2016 & the beginning of the year.

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The safety issue is not an issue of recall. Avanos Mediacal Cortrak 2 Avanos doesn't ask healthcare providers to return the devices and to make sure they are using them in a safe manner.

A feeding tube that is not properly placed could cause damage to vocal cords and lungs. It may also cause serious injury or even death. Avanos was alerted of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. These events were all linked to the Cortrak*2 system that guides the position of a feed tube.

There are a variety of injuries which have been reported such as respiratory failure, collapsed lung and lung infections.

The FDA reminded users of the need to verify that they have placed a nasogastric tube in accordance with their institution guidelines in the March 21 field correction notification. Avanos requested that users add the safety announcement to the system's operation manual and confirm that they have notified Avanos that the change was accepted.

Avanos stated that it will shortly issue a updated labeling for its product. This will include directions to map the placement of the tube in line to their facility's policies.

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This is the second FDA warning this year about the use of enteral feeding tubes. In February, the FDA issued an safety communications informing parents and health professionals of the dangers of strangulation due to the use of feeding tubes by children.

Following two reports of deaths in 2021, the notice was sent. The notice was issued following two reports of death in 2021. feeding tube placement In each case, the tubing system was discovered to be tied around necks of patients under the age of 2.

"While the FDA considers that strangulation caused by tubes for feeding tubes in the gastrointestinal tract of children is not likely to result in fatal injury or death caregivers and healthcare professionals should be aware of the potential risk," the FDA stated in the notice. It also noted that other similar cases might not have been reported to the FDA.


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