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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There were 60 injuries as well as 23 deaths due to this issue.

This recall was identified by the FDA as classified as a Class I recall. It is the most serious type of recall. The devices could cause severe injuries or even death.

Avanos Medical feeding tube Sam Brusco Associate Editor05.16.22

The FDA has confirmed Avanos Medical's recall of their Cortrak*2 intramuscular access system. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Avanos Mediacal Cortrak 2 Starting on March 21, 2016, 629 devices were recalls in the U.S.

Cortrak*2 lets clinicians insert medical feeding tubes inside the stomach or small bowel of patients who require nutritional assistance.

The recall of the system was due to the deaths and injuries of patients resulting from misplacement of nasocentric/nasogastric tubes. These tubes are used to aid in the placement of them. An incorrectly placed nasogastric/nasoenteric tube can cause serious injury or even death.

As per Avanos safety communication the problem has led to more than 23 deaths and 60 injuries. There have been several adverse events, including pneumothorax, respiratory failure, perforation as well as pleural effusion and pneumonia.

This recall will be used to revise Cortrak*2's instructions for use, intended uses, and instruct users to verify tube placement according to institutional protocols before using the tube to provide nutritional benefits.

feeding tube placement Avanos Mediacal Cortrak 2 Clinicians were also asked to attach the correction notice concerning the issue in the operating book and then return the acknowledgement form along with the notification to Avanos. The users will shortly receive an update to the labels and confirmation that tubes were placed in accordance with the institution's policies.


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