Recall of Some Sleep Aid Devices Heads Into Second Year

Without the help of a CPAP machine, Don Peteuil said he stops breathing 68 times an hour while he sleeps.

“The doctors told me if that was not treated, eventually, I may not restart breathing. The CPAP was very critical to me,” Peteuil said.

Last year, Philips announced a voluntary recall of around 5 million CPAP, BiPAP and ventilator devices, including the model prescribed to Peteuil, saying the foam used to reduce sound could break down, be swallowed or inhaled by the user, and degrading foam could be toxic or carcinogenic.

“I registered day one, within hours of getting the notice,” Peteuil said.

A status check on Philips’ online patient portal earlier this week showed Peteuil’s device is registered, but he was yet to receive it.

“I just see a very lackadaisical, nonurgent response, which is amazing because it's such critical equipment for so many,” he said.

Philips said it expects to repair or replace around 5.5 million devices around the world. To date, Philips Respironics has produced 3 million replacement devices and repair kits with 1.4 million of them shipped to the U.S.

In an email to NBC Responds, the company shared, in part, “In an average year, Philips Respironics produces and distributes around one million sleep devices. In the meantime, we have scaled up production by a factor of 3, despite global supply chain challenges, but inevitably it still takes time to remediate around 5.5 million devices.”

Philips also said it’s increasing production capacity and expects to complete around 90% of recall production and shipments in 2022.

Philips pointed to additional studies, including two showing no statistical difference in cancer risk between obstructive sleep apnea patients who used Philips Respironics pap devices versus other brands.

The Food and Drug Administration told NBC Responds it doesn’t generally comment on specific studies and that Philips’ Class I recall remains ongoing. Class I is the most serious type of recall.

Philips’ update online explains the overall guidance for health care providers and patients in the recall notification remains unchanged. The company said it’s committed to addressing all devices affected by the recall.

“Words mean nothing. Action is everything, right? Action is king. I'll believe it when I see it at this point,” Peteuil said.

After we reached out to Philips, Peteuil received his device in the mail.

HOW TO CHECK YOUR DEVICE, REGISTER

Click here for a list of Philips Respironics machines impacted by the recall, according to the FDA.

If your device is impacted by the recall and you haven’t registered, you can start here.