JACKSONVILLE, Fla. — (Editor's Note: The video above is from an unrelated report)
The U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics has recalled certain BiPAP and CPAP masks due to a serious safety concern.
The U.S. Food and Drug Administration says more than 17 million masks are impacted by this recall.
BiPAP and CPAP masks help people with obstructive sleep apnea, respiratory insufficiency or respiratory failure — health conditions that cause pauses in breathing during sleep.
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.
The FDA says medical devices that could potentially be affected by these magnets include brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators, ventriculoperitoneal shunts, ocular implants and more.
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The magnets could also affect mask users who have metallic objects in their body, such as shrapnel or splinters.
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.