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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This issue has caused more than 23 deaths and 60 injuries.

The recall has been classed by FDA as a class I recall. This is the most serious form of recall. These devices can cause grave injuries, or even death.

Avanos Medical Sam Brusco Associate Editor05.16.22

The FDA has identified Avanos Medical as the one responsible for recalling its Cortrak*2 system of enteral access. 629 devices, distributed between 2016 - 2022, were recalls by the U.S. starting on March 21.

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

The recall of the system was due to injuries and deaths of patients due to the incorrect placement of nasocentric/nasogastric tubes. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ These tubes assist in insertion. Cortrak 2 eternal access system A wrongly placed nasogastric or nasal tube could cause severe injuries or even death.

According to Avanos' safety communications there were 60 injuries and 23 deaths attributed to this incident. Adverse events reported included pneumothorax, respiratory failure, perforation, pneumonia, and pleural effusion.

Avanos Medical feeding tube Cortrak*2 has utilized the recall process to make revisions to its instructions to use. The new instructions provide users with a way to ensure that the tubes are placed according to institution protocols before using them to deliver nutrition.

Clinicians were instructed to attach the relevant field correction notice to the operating manual. Avanos Mediacal Cortrak 2 They should also return the acknowledgement slip that came along with the Avanos notification. The company hopes to soon give users with an updated labels. This will include confirmation that tube placement was done according to institutional guidelines.


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