Sept. 7, 2022 -- Medical device maker Philips Respironics is recalling some masks used with breathing machines because of potential risk of serious injury, the U.S. Food and Drug Administration has announced.

The masks have magnetic headgear clips or straps that can interfere with implanted metallic medical devices and cause injury or death, the FDA said in its announcement. Harm can occur to people using the mask or people near them.

“The recalled masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place,” the FDA announcement said. “The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments.”

The masks can be used with other makers’ BiPAP and CPAP machines.

The masks can adversely affect people using devices such as pacemakers, implantable cardioverter defibrillators, metallic stents and aneurysm clips.

Potential effects include pressure on the eye or brain, irregular heartbeat, failure to shock, compression of the brain, and seizures, depending on the device implanted.

Philips Respironics has distributed more than 17 million masks with magnetic clips, the company said.

The FDA said the company has received 14 reports of injuries after use of the masks as of Aug. 30. Those included pacemaker interference and failure leading to replacement.

Reuters reported that the FDA is working with Philips on the situation and continuing to monitor developments.

Reuters: “Philips recalls some masks used with respiratory devices over safety concerns”

FDA: “Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication”

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