SILVER SPRING, Md., Sept. 6, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. More than 17 million masks are impacted by this recall. BiPAP and CPAP machines help people with obstructive sleep apnea, respiratory insufficiency or respiratory failure — health conditions that cause pauses in breathing during sleep.
What you need to know:
The recalled masks are worn by a person when using a BiPAP or CPAP machine and have magnets that connect the mask components to hold the device in place.
The magnets can potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask, such as a bed partner, who have such devices. Medical devices that could potentially be affected by these magnets include brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators, ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants or any metallic implanted medical device affected by magnets.
The magnets could also affect mask users who have metallic objects in their body, such as shrapnel or splinters in their eyes, including people near the patient wearing the affected mask, such as a bed partner.
Five mask types are affected by this recall: the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks.
To date, Philips reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks. The FDA is providing recommendations in a safety communication for patients, caregivers and health care providers concerning use of the recalled masks with magnets, which patients may be using with Philips BiPAP and CPAP machines or those of other manufacturers.
"This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "We strongly encourage providers and at-risk patients to review this important safety information and follow our recommended actions to reduce the potential for harm from these products."
This recall is not associated with the polyester-based polyurethane (PE-PUR) foam issue for certain ventilators, BiPAP machines and CPAP machines recalled in June 2021. However, this recall affects masks used with some of the devices that were recalled in June 2021.
The FDA is committed to ensuring the public is kept informed of any additional issues regarding these recalled masks and other developments involving the prior recalls of Philips ventilators, CPAP and BiPAP machines. The agency will continue to provide updates when available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration