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

Seven years after adversity for Avanos Medical's enteral feeding tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has given the most serious of designations for a recall of the product.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a display monitor. When they are 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 tip placement and reducing the risk of complications.

Despite that mission, however, the system has been implicated in numerous injuries to patients that led Avanos to issue a recall earlier this year of all Cortrak*2 units used between January 2021 and January 2022--totaling nearly 630 devices first distributed between April 2016 until the beginning of the year.

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The safety incident isn't a recall, in the strict sense: Avanos is not asking health professionals to return the device back to its manufacturer but rather to ensure they're using the devices correctly.

A feeding tube that is not correctly inserted can cause serious injuries or even death. Cortrak 2 eternal access system Avanos was informed of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. The incidents were all linked to the Cortrak*2 system that guides the position of a feed tube.

There are several injuries which have been reported such as respiratory failure, collapsed lung, and lung infection.

Avanos Medical feeding tube According to FDA, in its March 21 field correct notice, the Georgia-based firm warned users to "confirm the placement of nasogastric and nasaloenteric pipes according to the policies of the institution". Avanos has asked patients to add a safety warning to their operating manual and to confirm they've updated their manuals.

Avanos has stated that it will soon issue a new label for its device. Cortrak 2 eternal access system feeding tube placement The labeling will contain the direction for mapping the tube's location, in accordance with their facility policies.

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This is the FDA's third caution regarding the use of an enteral tube for feeding use. Cortrak 2 eternal access system The FDA issued a safety communication in February warning parents and healthcare professionals about the risk of strangulation when children are feeding tubes.

This announcement was made due to two deaths reported in 2021. Each time, the notice was followed by two deaths in 2021.

"The FDA believes that death and serious injuries resulting from strangulation using enteral feeding set tubing for children is extremely rare. However, healthcare providers and their caregivers should be aware that these events can and do happen," the FDA said in its notice. The agency suggested that similar incidents could not yet be reported to FDA.


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