FDA Recalls Feeding Tube Placement Devices After Serious Injuries and Deaths
Federal safety officials have announced a Class I recall for a feeding tube guidance system, following reports of patient deaths and injuries.
The U.S. Food and Drug Administration (FDA) announced the Cortrak*2 Enteral Access System feeding tube recall on May 16, after the manufacturer received serious injury and death reports resulting from incorrectly inserted nasogastric or nasoenteric tubes.
According to the recall announcement, federal regulators have become aware of at least 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the CORTRAK*2 Enteral Access System, since 2015.
The recalled systems are designed to help trained health care personnel place medical feeding tubes into the stomach or small bowel of patients requiring nutrition through tube feeding. However, reports suggest that patients have experienced respiratory failure, collapsed lungs, perforation of the lung, esophagus or bowel, lung infections, and fluid buildup in the space between the lungs and chest cavity after accidental feeding tube misplacements.
The recall includes approximately 629 units of the Avanos Medical Cortrak*2 Enteral Access System that were distributed to healthcare facilities in the U.S. from April 1, 2016 to January 1, 2022.
Avanos Medical issued a field correction notice on March 21, 2022, warning customers of the potential adverse health events that could result from misplaced feeding tubes, and instructed physicians to confirm placement of nasogastric and nasoenteric tubes according to institutional policies.
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Avanos Medical announced it would update the labels to include steps for users to confirm placement of nasogastric and nasoenteric tubes according to institutional policies before use in the near future.
The FDA has given the feeding tube recall a Class I designation, indicating it is the most serious of its kind, and that the problems with the product have a high probability of resulting in serious or life threatening adverse health consequences, including death.
Customers with questions regarding the recall are encouraged to contact Avanos Medical by phone at 470-448-5444 or by emailing email@example.com. Any and all adverse reports arising from the devices should be reported directly to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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