Sleep apnea device recall drags on

A massive recall of millions of sleep apnea machines has stoked anger and frustration among patients, and U.S. officials are weighing unprecedented legal action to speed a replacement effort that is set to drag into next year.

Sound-dampening foam in the pressurized breathing machines can break down over time, leading users to potentially inhale tiny black particles or hazardous chemicals while they sleep, manufacturer Philips warned in 2021.

Philips initially estimated it could repair or replace the units within a year. But with the recall expanding to more than 5 million devices worldwide, the Dutch company now says the effort will stretch into 2023.

That’s left many patients to choose between using a potentially harmful device or trying risky remedies, including removing the foam themselves, buying second-hand machines online or simply going without the therapy.

The devices are called continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep passageways open during sleep.

Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.

Most patients are better off using a recalled device because the risks of untreated sleep apnea still outweigh the potential harms of the disintegrating foam, physicians say. But doctors have been hard pressed to help patients find new machines, which generally cost between $500 and $1,000, and were already in short supply due to supply chain problems.

Last March, the FDA took the rare step of ordering Philips to expand its communication effort, including “clearer information about the health risks of its products.” Regulators estimated then that only half of U.S. consumers affected had registered with the company. The agency hadn’t issued such an order in decades.

The FDA has received more than 70,000 reports of problems attributed to the devices, including pneumonia, infection, headache and cancer. Such reports aren’t independently confirmed and can’t prove a causal connection. They can be filed by manufacturers, patients, physicians or attorneys.

Jeffrey Reed, of Marysville, Ohio, had been using his Philips machine for about a year when he began seeing black specks in the tubing and mask. His equipment supplier said the debris was caused by improper cleaning, so he continued using it.

Over the next seven years, Reed says he experienced persistent sinus infections, including two bouts of pneumonia, that didn’t resolve with antibiotics. After hearing about the recall, he suspected the foam particles might be playing a role.

“Once I got off their machine, all of that cleared right up,” said Reed, 62, who obtained a competitor’s device after several months. Like other users, Reed can’t definitively prove his problems were caused by Philips’ device.

More than 340 personal injury lawsuits against Philips have been consolidated in a Pennsylvania federal court and thousands more are expected in coming months. 

Like the vast majority of U.S. CPAP users, Reed got his device through a medical equipment supplier contracted by his insurer. The company went out of business before the recall and he never heard from them about a replacement.

In May, the FDA put Philips on notice that it was considering a second order that would force the company to improve and accelerate its repair-and-replace program.

Medical device companies typically conduct recalls voluntarily, and former FDA officials say the agency has never actually used its authority to force additional steps.




Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device at his home Thursday, Oct. 20, 2022, in Marysville, Ohio. The device is part of a massive global recall of breathing machines triggered by sound-dampening foam that can break down, releasing potentially harmful particles and chemicals. (AP Photo/Jay LaPrete)