Washington — The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the United States under a tentative deal with regulators that could cost the company nearly $400 million.
Manufacturing giant Philips has recalled more than 5 million pressurized breathing devices due to the risk that their internal foam breaks down over time, leading users to inhale small particles while they sleep.
The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years, frustrating patients in the U.S. and other countries.
The Dutch company said it agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The agreement has not yet been closed and will have to be approved by a US judge. Philips executives revealed the tentative deal during a quarterly earnings update.
Under the terms of the agreement, Philips would continue to service recalled machines in the U.S., but would not be able to sell new machines until it complies with several corrective actions set forth by the FDA. Company executives said they have set aside $393 million to meet the expenses needed to comply.
The company promised it would put “safety and quality at the center of everything we do with a higher level of responsibility,” Philips CEO Roy Jakobs told analysts and investors.
The FDA website warns patients that risks from ingesting sound-deadening foam could include headache, asthma, allergic reactions and more serious problems. In November, the agency issued a new warning that the machines can overheat and, in rare cases, cause fires.
The agency said it cannot comment on Philips’ announcement until a final agreement is “signed and filed with the court.”
In 2022, the FDA took the unusual step of ordering Philips to step up its communication with customers about the recall, including “clearer information about the health risks of its products.” At the time, the agency estimated that only about half of people in the U.S. with affected machines knew they had been recalled.
Customers trying to get refunds or new or refurbished devices from the company have reported months of delays.
The devices are called continuous positive airway pressure or CPAP machines. They force air through a mask to keep the passageways open during sleep.
Untreated sleep apnea can cause people to stop breathing hundreds of times a night, causing dangerous drowsiness and an increased risk of heart attack. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.
The latest announcement does not resolve 675 personal injury lawsuits filed against the company over the devices. Those lawsuits have been consolidated in federal court in Pennsylvania.
Philips faces similar legal actions in Canada, Australia, Israel and Chile, according to the company’s update.
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