Notes

Avanos Medical faces Class I recalls for its feeding tube system that has been linked to 23 deaths since 2015

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

https://www.productsafety.gov.au/recalls/avanos-medical-australia-pty-ltd-%E2%80%94-mic-gastrostomy-feeding-tubes-expanded-recall The Cortrak*2 Enteral Access System includes an electromagnetic stylet as well as an external receiver, and a display monitor. When they are used together the system provides live video feeds of the placement of medical-grade feeding tubes into the stomach of a patient, or in the small bowel, with the goal of improving the precision of the tube's tip positioning and reducing the risk of complications.

Avanos was not happy with the mission and launched an recall of all Cortrak*2 units used between January 2021 and January 2022. The recall included nearly 630 devices which were distributed between April 2016 & the start of this year.

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The safety issue is not an issue of recall. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system Avanos doesn't ask healthcare providers to return the devices however, it is a way to ensure they are using them in a safe manner.

If a tube for feeding is placed incorrectly and is not properly inserted, it can cause damage to the vocal cords, lungs or trachea, potentially leading to serious injury or death. Avanos was alerted of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. The incidents were all linked to the Cortrak*2 system, which guides the position of feed tubes.

Some of the injuries reported include respiratory failure and collapsed lung infected lung, as well as holes in the walls of the esophagus and the lungs.

According to FDA the Georgia-based firm has reminded patients in the March 21 Field Correction Notice to "confirm the use of nasogastric tubes and nasoenteric tubes according to institutional guidelines". https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its Avanos Mediacal Cortrak 2 Avanos Medical Avanos advised users to attach the safety notification to the operation manual of the system and verify that they have notified Avanos that the update was received.

Avanos announced that they would soon issue an updated labeling for the device. The label will contain the directions to put tubes according to their policies.

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The FDA has issued a second warning about tube feeding into the gastrointestinal tract this year. In February, the FDA issued an safety message to parents and healthcare professionals about the possibility of strangulation among children using feeding tubes.

The announcement followed two instances of death in 2021. Each time the notice was followed by two deaths in 2021.

"The FDA believes that death and serious injury caused by strangulation with enteral feeding set tubing for children is uncommon. But, healthcare providers, and caregivers, should be aware that these events can and do happen," the FDA said in the notice. The FDA suggested that similar cases might not yet have been reported to FDA.

feeding tube placement
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