Federal regulators are heightening their warning about devices made by Philips Respironics used to treat obstructive sleep apnea, saying the products “may cause serious injuries or death.”
Philips recalled more than 5 million continuous positive airway pressure (CPAP) machines in June 2021 because foam inside the units meant to reduce noise was breaking off and blowing into users’ mouths. Inhaling the foam can cause “serious injury which can be life-threatening,” Philips wrote in its company recall at the time.
The company tried to fix some of the machines, but the repaired ones have also been recalled, according to the U.S. Food and Drug Administration.
“The FDA has identified this as a Class I recall, the most serious type of recall,” the agency said Friday in issuing a new alert about the the devices. The repaired CPAP machines were given the wrong or a duplicate serial number when Philips re-programmed them, the FDA said.
The error can cause the devices to deliver the wrong prescription to sleep apnea patients, or fail to offer any therapeutic benefits, the FDA said. That could lead to respiratory failure or heart failure, officials said. Philips has received 43 complaints about the reworked machines, although no injuries or deaths have been reported.
“Incorrect therapy or therapy failure may lead several health conditions such as respiratory failure, heart failure, serious injury and death,” the FDA said.
In a statement on Friday, Philips acknowledged that some of the repaired CPAP devices weren’t working properly, saying that “limited amount (1,200) of remediated first-generation DreamStation CPAP devices had been incorrectly programmed with either an incorrect serial number or a duplicate serial number.”
Philips also said it has identified which of its machines may be delivering faulty prescriptions and is notifying patients so their devices can be replaced.
“To date, we are more than halfway with the shipments of replacement devices to patients,” the company said.
The 2021 recall was for 20 different Philips devices, including its A-Series BiPAP ventilators and the DreamStation CPAP machines. In December, the company also recalled its Trilogy 100 and 200 style ventilators.
Nearly 100,000 complaints
About 30 million people in the U.S. suffer from sleep apnea, a disorder in which someone’s airways become blocked during rest and interrupts breathing, according to 2022 data from the American Medical Association.
The FDA has received more than 98,000 complaints about the original Philips recall since April 2021. Some of the complaints included reports linking the devices to cancer, respiratory problems, pneumonia, chest pain, dizziness and infections. As of the end of 2022, the FDA had received reports of 346 deaths linked to claims about the foam problems, according to the agency.
Dozens of sleep apnea patients have filed lawsuits against Philips related to the CPAP machines. One such patient, Carrie Markham of Florida, said she is suing because she hasn’t received a replacement in two years. Markhamlast month that she found out about the recall from Facebook, rather than a notification from the company.
In a statement in February, Philips said it tested its machines and found “no conclusive data linking these devices and the deaths reported” by the FDA. The company commissioned additional testing after the recall and .