Notes

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

After seven years' of failures for Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placement Systems has been recalled by the FDA has issued the most severe recall orders.

Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also comes with a display screen monitor. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical The system can be utilized in conjunction with the system to stream a live video that shows the process of inserting a medical feed tube in the stomach of a patient. The procedure is performed in the hope of increasing precision and reducing the risk of complications.

Avanos was not happy with the results and announced an recall of all Cortrak*2 units used between January 2021 and January 2022. Avanos Mediacal Cortrak 2 https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its The recall affected more than 630 units that were distributed between April 2016 and the start of this year.

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The safety incident isn't a recall, in the literal sense of the word: Avanos is not asking healthcare providers to send the devices back to the manufacturer, but rather to ensure they're using them correctly.

If a feeding tube is incorrectly inserted, it can damage the vocal cords, lungs, or trachea which could result in serious injury or death. Indeed, Avanos has received reports of deaths of 23 and 60 injuries since the year 2015, the FDA stated that all of them were related to the the Cortrak*2 system to guide the installation of a feeding tube.

A variety of injuries have been reported including respiratory failure (collapsed lung) lung infection, holes inside the esophagus and walls.

Avanos Mediacal Cortrak 2 In the March 21 field correction notice, the Georgia-based company advised users to "confirm the placement of nasogastric as well as Nasoenteric tubes in accordance with guidelines of the institution" according to the FDA. They're also required to add the safety note to the operating manual for the system and confirm with Avanos that they've received the latest version of the notice.

Avanos has announced that they will soon issue a new label for the device. This labeling will include the direction for mapping the location of the tube in line with their facility policies.

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This is the second warning the FDA has issued in the past year in regards to enteral feeding tubes. In February, the FDA released a safety communication that warned parents and health professionals of the possibility of strangulation due to the use of feeding tubes for children.

Following two death reports in 2021, this warning was released. A tubing system that was not being monitored by staff or caregivers was wrapped around necks and necks of children less than two years old.

"While the FDA believes that serious injury or death caused by strangulation from tubing for feeding through the enteral system in children is rare healthcare professionals and caregivers should be aware of the fact that these incidents could and do happen," the agency said in its notice and suggested that similar incidents may not have been reported to the FDA.


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