Recall: Popular Sleep Apnea Machines Linked to Over 500 Deaths
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The FDA announced that recalled CPAP and BiPAP machines have been tied to hundreds of deaths.
The CPAP and BiPAP machines were initially recalled in June 2021.
CPAP and BiPAP machines are both worn at night to help those with sleep apnea.
Last week, the U.S. Food and Drug Administration (FDA) announced that previously recalled sleep apnea machines have now been tied to the deaths of over 550 people.
In June 2021, the FDA first announced the recall of Philips Respironics BiPAP and CPAP devices—which are worn overnight while someone sleeps—as well as ventilators, saying the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in the affected machines, has the potential to break down.
If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device, the agency cited. These issues could potentially lead to serious injury and require medical intervention to prevent permanent injury.
Since the recall, the FDA has received more than 116,000 reports of actual or suspected incidents of foam breaking down in the machines and 561 deaths reportedly associated with (or suspected to be associated with) the breakdown of the PE-PUR foam.
If you have a Philips breathing machine, search the serial number here to find out if it’s part of the recall. If you have a recalled device, the FDA urges patients to connect with their healthcare provider to decide the best course of action.
BiPap and CPAP machines are both types of noninvasive ventilation that help you breathe by delivering pressurized air through a mask worn over the face while sleeping. These devices are worn at night to help those with sleep apnea, which is a potentially serious sleep disorder in which breathing repeatedly stops and starts, per the Mayo Clinic.
While both machines are used to treat the same condition, there are a few key differences between the two devices. Per the FDA safety notice, a BiPAP machine pumps air under varying pressure into the airway of the lungs, using a higher pressure when you breathe in and lower pressure when you breathe out. A CPAP machine keeps your airway open by providing a stream of air at a continuous pressure through a mask.
If you snore loudly and feel tired even after a full night’s sleep, you might have sleep apnea, according to Mayo Clinic. While sleep apnea can typically be managed through either BiPAP or CPAP machines, the condition may put you at a higher risk of Alzheimer’s disease and stroke. If you suspect that you may have sleep apnea, it’s important to see your doctor and undergo a sleep study to find out how to best improve your sleep and overall health.
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