Avanos Medical faces a Class I recall for its feeding tube system connected to 23 deaths in 2015
After seven years in which Avanos Medical's intravenous tube placement device was plagued by unfortunate luck and a lack of trust, the FDA has issued its most serious directive to recall the product.
feeding tube placementAvanos Mediacal Cortrak 2 Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. When used together it provides an live stream of the positioning of the medical feeding tube in the stomach of a patient, or in the small bowel, with the intention of improving the accuracy of the tube's tip placement and reducing the risk of complications.
Despite that mission however, the system has been linked to numerous injuries to patients that led Avanos to launch a recall earlier this year of all Cortrak*2 units used between January 2021 and January 2022, totalling around 630 devices initially released between April 2016 and the beginning of the year.
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The safety incident isn't a recall, in the strict sense: Avanos is not asking healthcare providers to send the device back to its manufacturer, but rather to ensure they're using them in a safe manner.
Incorrectly inserting the feeding tube incorrectly can cause damage to vocal cords or lungs. Avanos Medical According to FDA, Avanos received reports of 23 deaths and 60 injuries since 2015, all related to the FDA's usage of the Cortrak*2 system to guide the placement of the feeding tube.
Many different injuries have been documented, which include respiratory failure (collapsed lung) lung infection, holes inside the walls and esophagus.
According to FDA, the Georgia-based company issued a field correction note that reminded users to confirm the position of nasogastric tubes and tubs for the nasoenteric system according to institution policies. Avanos has asked users to add a safety warning to their operating manual and to confirm they've updated their manuals.
Avanos announced that it will soon release a updated labeling for its product. It will also include instructions to map the placement of a tube in accordance to the policies of their facility.
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This is the FDA’s second caution in relation to tube feeding through the stomach. In February, the FDA published an safety communications that warned parents as well as healthcare professionals about the risk of strangulation due to the use of feeding tubes for children.
Two deaths in 2021 were reported to the notice. Each time, the notice was followed by two deaths in 2021.
Cortrak 2 eternal access system "While the FDA believes that strangulation from enteral feeding tube tubing in children is unlikely to cause fatal injury or death, caregivers and healthcare providers must be aware of the potential risk," the FDA stated in the notice. The FDA also stated that similar incidents could not have been reported to the FDA.