The FDA determined that Avanos Medical’s recall of some of its Cortrak 2 enteral access systems is Class I, the most serious kind.

Alpharetta, Georgia-based Avanos Medical is recalling certain Cortrak 2 general access systems due to reports of patient injuries and deaths following nasoenteric or nasogastric tube misplacement. The recall includes all serial numbers of the Cortrak 2 system used between January 2021 and January 2022. There have been 629 devices recalled, according to an FDA warning letter.

Avanos Medical reports there have been 60 injuries and 23 patient deaths related to misplacement of the nasogastric feeding tubes while using the Cortrak 2 enteral access system.

Adverse events reported include respiratory failure, collapsed lung, perforation, pneumonia and pleural effusion. Healthcare personnel who use Cortrak 2 and people who have a feeding tube placed with assistance from Cortrak 2 are affected by the recall.

Avanos Medical designed Cortrak 2 enteral access system to help trained healthcare professionals place medical feeding tubes into the stomach or small bowel of patients who need to receive nutrition through the tube.

The company issued an urgent field correction notice in March that included instructions to confirm the placement of nasogastric and nasoenteric tubes according to institutional policies; attach the field correction notice about the issue to the operator’s manual and return the acknowledgment form included with the notice to Avanos Medical. The company said it intends to provide users with updated labeling that includes the steps for users to confirm the placement of nasogastric and nasoenteric tubes.