Magnets in the recalled masks, used in breathing machines for sleep apnea, can interfere with pacemakers and other lifesaving medical devices.
Philips Respironics has voluntarily recalled more than 17 million sleep apnea masks with magnetic parts that can cause implanted medical devices with metal parts to malfunction — including pacemakers and implanted defibrillators.
Masks involved in the recall work with bilevel positive airway pressure (also known as bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines that are used to treat sleep apnea. All of the recalled masks — the Amara View full face, DreamWisp nasal, DreamWear full, Wisp and Wisp Youth nasal, and Therapy mask 3100 NC/SP — use magnets to headgear clips to attach the headgear straps to the masks.
“The recalled masks have magnets and can cause potential injuries or death when use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body,” the U.S. Food and Drug Administration (FDA) said in a September 6 statement.
As of August 30, 2022, Philips reported 14 serious injuries related to these masks, according to the FDA. The FDA described several types of injuries, including a pacemaker that failed and needed replacement and an automatic implanted defibrillator that failed and needed resetting. Other serious events related to the recalled masks included cases when patients developed an abnormal heartbeat, seizures, cognitive problems, headaches, and irregular blood pressure.
No deaths had been reported as of August 30, the FDA said.
Any implanted medical device containing a metal parts might malfunction when in proximity to magnets in the recalled masks, the FDA reported. Magnets can interfere with a wide range of devices including aneurysm clips, cerebral spinal fluid shunts, embolic coils, hearing implants, implantable cardioverter defibrillators, insulin pumps, magnetic dentures, metallic gastrointestinal clips, metallic stents, neurostimulators, pacemakers, and some joint replacements, Philips said in a statement.
“Use of the mask is contraindicated for patients and their household members, caregivers, and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets,” Philips said.
Patients who have implanted devices or who are in close proximity to somebody with an implanted device should stop using the mask and immediately consult with a physician to determine if an alternative can be used. They should also switch to a nonmagnetic mask.
Masks involved in the recall may still be used if patients or people in close proximity to them don’t have implanted metallic medical devices or metal objects in the body, Philips said. Patients can contact Philips Respironics’ customer service at 800-345-6443 for more information about nonmagnetic mask options.
This recall may affect some masks used with devices involved in a previous recall in June 2021, the FDA said. Philips previously recalled certain ventilators and BiPAP and CPAP machines because foam used to reduce sound and vibration could break down, releasing black pieces of foam and chemicals that might be inhaled or swallowed, according to the FDA.
“This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the September 6 statement. “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.”
When people have sleep apnea, their breathing can be interrupted hundreds of times a night, leading to lack of oxygen and an increased risk of high blood pressure, heart disease, stroke, and diabetes, according to the Cleveland Clinic. A CPAP machine can help prop open airways and minimize breathing interruptions by delivering continuous air through the nose and mouth all night. A BiPAP machines deliver two different levels of pressure to aid air flow during both inhalation and exhalation for patients with more severe sleep apnea.
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