561 Deaths Linked To Recalled CPAP, Other Devices, FDA Says

ACROSS AMERICA — A recalled Philips medical device to treat obstructive sleep apnea and other breathing difficulties has been linked to 561 deaths since April 2021, the Food and Drug Administration said this week.

The agency said that since April 2021, it has received more than 116,000 reports of the polyester-based polyurethane foam used to reduce the sound and vibration of the machines breaking down and blowing gas and pieces of plastic into the airways of those using them.

Affected machines are Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices.

“These issues could potentially result in serious injury and require medical intervention to prevent permanent injury,” the agency said.

The Dutch medical device maker said in a Securities and Exchange Commission filing that it would stop selling the machines in the United States as part of $479 million class-action settlement agreement with the FDA and Justice Department. The agreement, which still must be approved by a U.S. court, also requires the company to continue servicing existing machines but prohibits the sale of new ones until certain conditions are met. About 20 different models are included in the 5 million devices recalled in June 2021.

People who used the devices can now make claims for financial losses related to the purchase, lease or rent of the recalled devices. They are entitled to:

• A device payment award for each recalled device purchased, leased or rented;
• A device return award of $100 for each recalled device returned by Aug. 9, 2024; and or
• A device replacement award for money spent to buy a comparable device between June 14, 2021, and Sept. 7, 2023.

Users can determine their eligibility on the company’s settlement website, as well as look up the device serial number to see what payment award they might be entitled to.

Customers who return devices before the August deadline will receive a payment award without filing a claim form by using a prepaid sipping label.

Also, anyone who bought a comparable machine needs to file a device replacement claim form.