According to the U.S. Food and Drug Administration, Philips Respironics, a manufacturer of medical devices, is recalling certain masks used with breathing machines due to a possible risk of serious harm.
The FDA stated in its notification that the masks feature magnetic headgear clips or straps that could interfere with implanted metallic medical equipment and result in harm or death. People wearing the mask or those around could suffer harm.
According to the FDA notice, the recalled masks contain magnetic headgear clips to keep them in place while being used by a patient with a BiPAP or CPAP machine. The recalled masks can be used for a single patient at home or for multiple patients in a hospital or other therapeutic setting.
The masks are compatible with CPAP and BiPAP machines from other manufacturers.
People who use devices like pacemakers, implantable cardioverter defibrillators, iron stents, and aneurysm clips may experience negative effects from the masks.
Depending on the implanted device, potential side effects could include compression of the brain, pressure on the eye or brain, irregular heartbeat, failure to shock, and seizures.
According to the firm, Philips Respironics has supplied more than 17 million masks with magnetic clips.
According to the FDA, as of August 30, the company has received 14 reports of injuries caused by the usage of the masks. These included issues with pacemakers failing and needing to be replaced.
According to Reuters, the FDA is collaborating with Philips on the issue and continues to keep an eye on developments.