Notes

Avanos Medical faces a Class I recall over feeding tube system connected to 23 deaths that occurred in 2015

Seven years after adversity for the Avanos Medical enteral feeding tube placement system, the FDA has handed down its most serious designation for a recall of the device.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a display monitor as well as an electronic receiver. The system provides a live feed of medical tubes being inserted into the stomachs of patients or small bowels. Avanos Mediacal Cortrak 2 Avanos Medical This permits an improvement in tip placement precision and elimination of any complications.

Avanos Medical feeding tube Avanos was not pleased with the results and announced an recall of all Cortrak*2 units used between January 2021 & January 2022. Avanos Medical The recall affected nearly 630 devices which were distributed between April 2016 and the beginning of the year.

The incident that caused the safety issue isn't a recall in the strictest sense: Avanos does not ask healthcare providers to request that the device be returned to the maker. It's simply to make sure that they're using the device in a safe manner.

A tube for feeding that has not been properly inserted could cause grave injury or even death. Avanos Medical According to the FDA, Avanos received reports of 23 deaths and 60 injuries since 2015, all related to the FDA's use of the Cortrak*2 system to guide the installation of a feeding tube.

Many different injuries have been reported , including respiratory failure (collapsed lung), lung infection as well as pleural effusions, gaps in the walls, the esophagus, and the bowel.

According to the FDA the Georgia-based firm advised users in its March 21 field correct notification to "confirm the placement of nasogastric/nasoenteric tubs to the institution's policies". Avanos advised users to add the safety announcement to the operation manual of the system and verify with Avanos that the update was accepted.

Avanos indicated that it will soon issue updated labels for the device. They will also include the direction of where to place the tube in line the policies of Avanos.

This is the second caution that the FDA has issued this year with regard to feeding tubes for the enteral system. The FDA released a safety communications in February that warned parents, healthcare professionals, and children of the risk of strangulation through feeding tubes.

The notice came after two deaths reported in 2021. Each case included a tube that was placed around the neck of a baby under the age 2 while the patient wasn't being monitored by the staff at the hospital.

"While the FDA believes that strangulation caused by tube feeding into the enteral system in children is rare," the agency noted in the announcement. Avanos Medical It suggested that other similar incidents may not have been reported to the FDA.


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