Notes

Avanos Medical faces a Class I recall for its feeding tube system connected to 23 deaths in 2015

After seven years of unlucky luck for the feed tube inserter The FDA has given its most serious designation for the recall of the device.

https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Cortrak*2 Enteral Access System features an electromagnetic stylet, which includes an external receiver, a display monitor and an electronic receiver. It can be combined to stream a live video that shows the procedure of inserting a medical feeding tube in the stomach of the patient. This is done with the aim of improving accuracy and reducing complications.

In spite of that mission the system has been linked to a number of injuries to patients, causing Avanos to announce 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 until the beginning of the year.

The safety incident isn't recall in its true meaning: Avanos does not ask medical professionals to return devices to the manufacturer. Instead, it would like to make sure they're making use of the devices properly.

If a tube for feeding is incorrectly placed, it could cause damage to the vocal cords, lungs, or trachea and cause severe injury or even death. Avanos was informed of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system These events were all connected to the Cortrak*2 system that guides the positioning of the feeding tube.

Numerous injuries have been reported including respiratory failure (collapsed lung) lung infection as well as pleural effusions, gaps in the walls, the esophagus and bowel.

Avanos Medical feeding tube According to FDA in the March 21 Field Correction Notice the Georgia-based company asked users to "confirm placing of nasogastric (and nasal) tubes according to institutional policy." Avanos requested that users add the safety announcement to the operating manual for the system and then confirm with Avanos that the change was approved.

Avanos has announced that they will soon issue updated labels for the device. They will also include the instructions for how to place a tube in line the policies of Avanos.

This is the second FDA warning regarding enteral feeding tubes this year. In February, the FDA put out a safety message informing healthcare professionals and parents about the danger of strangulation when children use feeding tubes.

This notice was issued due to two deaths in 2021. The notice was issued following two reports of death in 2021. In each case the tubing system was discovered to have been tied around necks of patients under the age of 2.

feeding tube placement "While the FDA believes that strangulation using feed set tubing for enteral feeding in children is not common, healthcare providers should be aware of these events," the agency stated in its notice. This suggests that similar cases could not have been reported to the FDA.

feeding tube placement
Here's my website: https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas