Dive Brief:
- The Food and Drug Administration labeled Avanos Medical’s recall of a system to help place medical feeding tubes a Class I event following dozens of reports of patient injuries and deaths associated with the system.
- The company initiated the recall of the Avanos Medical Cortrak 2 Enteral Access System on March 21 and the FDA published the Class I recall in its database on May 13. Patient injuries and deaths have been reported due to feeding tubes being placed incorrectly with the use of the system, according to the agency's notice. “If a nasogastric or nasoenteric tube is inserted incorrectly, patients could experience damage to the vocal cords, lungs, or trachea, all of which can lead to serious injury or death,” the agency said. The recall will be made to update instructions for use and intended uses for the device.
- In a recall communication, Avanos reported that there have been 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the system since 2015, the FDA said.
Dive Insight:
Avanos’ Cortrak 2 system helps healthcare personnel place medical feeding tubes into the stomach or small intestine of patients who need to receive nutrition through the tube. According to the company’s website, the system provides “real-time” information about the tube’s location within a patient’s anatomy.
While the recall only affects 629 units in the U.S., safety issues with the system have increased in the last several years.
The FDA said that among the patient and death reports, adverse events have included respiratory failure, collapsed lungs, pneumonia, excess fluid in the space between the lungs and the chest cavity and a hole in the wall of the lung, esophagus or bowel.
Avanos sent field correction notice emails to customers with the device on March 18 and March 21, according to the FDA’s recall database entry. A company spokesperson said in an emailed statement that no devices will need to be withdrawn from the market.
Avanos told customers in a March 21 field action alert to stop using the “Anonymous Account Mode feature immediately” and that the device should only be used by qualified and trained users, according to a recall alert provided to MedTech Dive by the watchdog group ECRI.
“Use extreme caution in patients who are combative or who move excessively during placement, as the receiver unit may move, impacting the placement tracing. If a deviation from the midline is seen on the All-In-One Monitor display during advancement in the upper quadrants, or resistance is encountered, stop advancement of the system, remove the tube and stylet, and assess the patient for injury per institutional protocol,” the alert stated.
The FDA said in the recall notice that Avanos will provide users with updated labeling “in the near future.”
The recall affects devices manufactured between April 1, 2016, and Jan. 1, 2022.
