More than 2 years after recall, Philips CPAP users still waiting for replacement devices

We’re now two and half years into a massive CPAP machine recall by Philips Respironics.

More than 15 million devices worldwide were voluntarily recalled by Philips after it was revealed a noise-canceling foam inside could break down and be inhaled by the user while they sleep.

Despite the recall occurring approximately 30 months ago, some Chicagoans are still waiting for their replacement machine.

Some sleep apnea patients are still having to make a difficult choice each night: choose to not use the CPAP device prescribed by their doctor and risk not breathing while sleeping, or use the device and face the risk of a wide-range of illnesses, including cancer.

“When I lay down and fall asleep, my throat collapses, and I stop breathing,” said Steve Levin, a sleep apnea patient for more than a decade.

Levin is a traveling lecturer and his Philips CPAP machine has always been his number one carry-on.

“Once I take it out of my carrying case, I just need to plug this in,” said Levin. “So it’s very convenient.”

About three months after Levin bought his CPAP machine in 2021, he and millions of other Philips customers got recall letters stating foam breakdown in the CPAP machines could “result in serious injury which can be life-threatening” or “cause permanent impairment”.

“They’re concerned that an insulating material inside the machine will break down, that you’ll breathe it in and can cause cancer later. Philips disputes that,” Levin said. “But you know, how long do you want to roll the dice and take your chances on that?”

NBC 5 Responds found regulators have received roughly 100,000 reports of a wide range of injuries tied to the foam breakdown, including “cancer, pneumonia, asthma,” and “other respiratory problems.” The FDA said 346 potential deaths are among those reports.

“The idea that when I use it, I might be shortening my life a little bit…It is concerning,” said Levin, who still uses the machine when he travels.

While the recall took Levin by surprise, NBC 5 Responds found the problems at the heart of the matter were not a surprise to the Philips, according to inspection records from the FDA.

Inspections showed Philips knew about the degrading foam since at least 2015 through thousands of consumer complaints, and their own testing throughout the years, but still allowed the machines to be sold.

In response, Philips said they’re “working closely with the FDA to clarify and follow up on the inspectional findings.”

“I’m actually horrified to hear that. That’s it for [my] machine,” Levin said, who later told NBC Chicago that he would stop using the machine.

Yet 30 months after the recall, Levin still hasn’t received his replacement or the $500 cash option Philips is offering to some customers.

“Two years of delay. Two years that I’ve been using [the CPAP]. Apparently with more risk than I knew for cancer,” Levin said.

NBC 5 Responds reached out to Philips on Levin’s behalf, with Philips contacting Levin one week later to confirm his payment was now on its way.

“At this time, about 2.84 million new devices and repair kits have been produced to meet the U.S. registration demand. So far, 2.5 million remediated devices are in the hands of U.S. patients and Durable Medical Equipment providers (DMEs). In the U.S., we’ve now remediated about 99% of the sleep therapy device registrations that are complete and actionable,” a statement from Philips said.

In response to the length of delay Levin faced, Philips said the following:

“This is one of the largest recalls in the medical technology industry. The repair and replacement program is complex, due to the volume of devices to be addressed, as well as the scale of individual patient outreach.”

Levin’s still worried about the toll the device may have taken on his own health, and he’s upset the company recall warning wasn’t more urgent.

“I just think if they haven’t been upfront about what they’ve been doing, they should really be punished they treated this and led people to believe that it’s no big deal,” said Levin.

Senator Dick Durbin is now one of the congressional lawmakers calling for a federal investigation into Philips over their handling of the recall.

In September, Philips agreed to pay almost $500 million dollars in a settlement over the alleged health risks from the foam in their CPAP machines.