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Avanos Medical faces Class I recall for feeding tube system implicated in 23 deaths in the last year.

Seven years after unlucky luck for Avanos Medical's feed tube system, the FDA has handed down its most severe designation for a recall of the device.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver with an LCD monitor. When combined will provide live footage of the medical tube being placed into a patient's stomach.

Avanos Medical feeding tube Despite this goal it has been linked to many injuries sustained by patients, leading Avanos to issue an recall earlier in the year of all Cortrak*2 devices used between January 2021 and January 2022--totaling nearly 630 devices first distributed between April 2016 and the start of the year.

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The safety event doesn't constitute an recall in the strictest sense: Avanos doesn't ask healthcare professionals for the device to be returned back to the company that made it. It's merely to ensure that they're using it correctly.

Incorrectly inserting a feeding tube could result in damage to the vocal cords, lungs, or the trachea. Avanos Medical This can lead to serious injury, or even death. In fact, Avanos has received reports of more than 60 injuries since 2015 the FDA declared, all of which were linked to the the Cortrak*2 system to aid in the installation of a feeding tube.

A few of the injuries that have been reported include respiratory failure and collapsed lung infected lung, as well as holes in the walls the esophagus and lungs.

In the March 21 field correction notice, the Georgia-based company reminded users to "confirm the use of nasogastric or Nasoenteric tubes in accordance with institutional policies," according to the FDA. Cortrak 2 eternal access system Avanos recommended that patients include the safety warning and confirm with Avanos they received the updated.

Avanos announced that they will soon issue updated labeling to the device. It will include the directions to put the tube in accordance with their policies.

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This is the second FDA warning this year regarding enteral feeding tubes. In February, the FDA released an safety message warning healthcare providers and parents of the possibility of strangulation when children use tubes for feeding.

Following two reports of deaths that occurred in 2021, a notice was sent. The notice came in the wake of two reports of death in 2021. In each case the tubing system was discovered to be placed around necks of patients younger than age of 2.

Avanos Medical feeding tube "The FDA believes that strangulation by enteral feed set tubing children is uncommon, but healthcare providers and caregivers need to be aware that such instances can occur and can occur," the agency stated in the announcement. This suggests that similar instances could not have been reported to the FDA.


Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause