Notes

Avanos Medical faces a Class I recall over the feeding tube system that was linked to 23 deaths in 2015.

After seven years during which Avanos Medical's intravenous tube placement device was plagued with bad luck and mishaps, the FDA has given its most serious instruction to issue a recall.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an exterior receiver, and a display monitor. When used together, the system offers live video feeds of the placement of the medical feeding tube in the stomach of a patient, or in the small bowel, with the goal of improving the precision of the tube's placement and reducing the risk of complications.

Avanos announced an earlier year, affecting all Cortrak*2 units that were used between January 2021 to January 2022. The total number of affected devices was 630. devices. They were distributed in the first time from April 2016 to the beginning of the year.

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The safety event is not a recall in its literal sense: Avanos does not ask medical professionals to return devices back to the manufacturers. Avanos Medical Instead, it would like to ensure that users are using the devices properly.

A feeding tube that isn't correctly placed can result in severe injury or death. Avanos recorded more than 23 deaths and 60 injuries in the last year, FDA said. All of these were directly related to FDA's Cortrak*2 system that is used to insert the feeding tube.

These injuries could include respiratory failure, collapsed lungs, lung infections, pleural effusion and holes in the lungs' walls and esophagus as well as bowel.

According to FDA, the Georgia-based company issued a field correction notice reminding patients to confirm the placement of nasogastric tubes as well as tubs for the nasoenteric system according to institution guidelines. Avanos Medical Avanos has also asked them to add the note on safety to the operating manual for the device and verify that they've received the update.

Avanos announced that it will shortly release a new labeling system for the device. It will include a direction to plot a tube's placement in accordance with their facility's policies before using the system to help set up the tube.

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This is the second FDA warning on tube feeding into the gastrointestinal tract this year. Cortrak 2 eternal access system Avanos Medical In February, the FDA released a safety announcement to inform healthcare professionals and parents of the possibility of strangulation in children who use feeding tubes.

Two deaths occurred in 2021 and were not reported to the notice. The notice came in the wake of two reports of deaths in 2021. In both instances the tubing system was found to have been placed around necks of patients younger than age of 2.

"The FDA believes that strangulation with enteral feed set tubing children is not common, however healthcare providers and caregivers need be aware that these events can and do occur," the agency stated in the notice. This suggests that similar instances might not have been reported to the FDA.


Read More: https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A