Health tech company in talks with FDA about device that may have caused injury, death

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Medical technology company Avanos has issued a voluntary field correction for a vital hospital tool that may have led to injury or even death. 

Avanos initially told Fox News Digital that the company is in an "ongoing dialogue" with the Food and Drug Administration (FDA) on the matter and "cannot comment," but later added that "the FDA has not requested that Avanos conduct a product recall, and we have no expectation that it will do so."

The Cortrak 2 Enteral Access System helps healthcare providers fit feeding tubes safely into a patient so they avoid distributing food into sensitive areas of the body. On the Avanos website, it advertises the Cortrak 2 system as "a time-saving solution that benefits nurses of all levels, dieticians, and GI and ICU doctors." 

The company says that other systems can cause "increased pneumothorax risk, feeding delays, multiple x-rays and transports," implying their system avoids these issues with "real-time location information" and "on-screen visualization" on tube placement with a reduced need for x-ray confirmation. 

But a notice posted by the Canadian government under its "Recalls and safety alerts" page advises medical practitioners that Avanos conducted a voluntary field correction for the Cortrak 2 due to "modifications to the labeling of the device."

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"Reports of injuries and patient deaths related to misplacement of nasogastric feeding tubes while operating the device per labeled instructions for use (IFU) and intended use have been received," the notice stated. 

A copy of the field correction notice dated March 21, 2022 and obtained by Fox News Digital states that there have been reports of 60 injuries and 23 deaths due to misplacement of the system. The notice suggests that the hospital or user "confirm placement of the NG/NI tubes per institution protocol." The FDA stated in an online notice that the agency had received 51 medical device reports that included 11 reported deaths after pneumothorax - or a lung collapse - events occurred. 

The notice also explains that the company will retire the "Anonymous Account Mode," which, according to a British briefing notice, logs the entire placement video temporarily but does not record it. The alternative mode, "Accounts Mode," saves the videos to an external USB flash drive. 

Fox News reached out to the FDA for comment.

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Avanos previously faced legal issues with the Department of Justice when it labeled its surgical gowns as providing the highest level of protection against fluid and virus penetration. Avanos agreed to a deferred prosecution agreement and to pay $22 million, which covered victim compensation and criminal penalties. 

Mark Gardner and Theo Thompson, lawyers who specialize in MedTech & Pharma, told Fox News Digital that any such field correction would not shield the company from legal liability and likely serve as a temporary step while considering a wider recall with the FDA. 

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"The optics on a "Field Correction" vs. "Recall" are slightly better because a "Field Correction" signals that FDA or the manufacturer has not yet determined the product represents a serious health risk," Thompson explained. "However, the product liability risks to the manufacturer remain despite how the manufacturer describes it." 

"Avanos appears to be positioning this as a correction because they are modifying the labeling of their device without its physical removal from its point of use to some other location," he added. "It does not appear that FDA has requested, nor is the company issuing, a voluntary recall … which is usually followed by a press release, notification on the company website and more, depending the risk posed by the product." 

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Gardner raised the concern that even such a field correction and change in procedure might not reach those currently using the tech while the company rolls out its correction, despite the desire from the FDA to have companies make proactive corrections and not "slow-roll" a recall or correction while waiting on feedback.