For neurostimulators: compression of the brain, seizures, or lead migration, which may be fatal.For cardioverter defibrillators: may fail to shock, which may be fatal.For pacemakers: heart block or irregular heartbeat, which may be fatal.For aneurysm clips: disrupted suture lines or clip separation, which may be fatal.For cerebral spinal fluid and ventriculoperitoneal shunts: potential increased pressure on the eye or brain, which may be fatal.If the magnets affect the functioning or induce movement of certain implanted metallic medical devices or metallic objects in the body, the potential risks may include: Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field.Devices labeled as Magnetic Resonance (MR) Unsafe.Implantable ports and pumps (such as insulin pumps).Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants).Ocular implants (such as glaucoma implants and retinal implants intraocular lenses placed during cataract surgery are not impacted).Metallic cranial plates, screws, burr hole covers, and bone substitute devices.Intracranial aneurysm intravascular flow disruption devices.Cerebral spinal fluid shunts (such as ventriculoperitoneal shunt).Magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head.Neurostimulators (such as hypoglossal nerve stimulators).Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary).

Implantable cardioverter defibrillators.The recalled masks have magnets that can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted metallic medical devices or metallic objects in the body, such as: The Magnets in the Recalled Masks May Affect Certain Metallic Medical Devices or Metallic Objects in the Body Presenting a Potential Risk Figure 4: Wisp and Wisp Youth Nasal Mask.The recalled masks are for patients weighing more than 66lbs (30kg), except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP which are for patients seven years of age and older weighing more than 40lbs (18kg). The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. 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. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. These potential adverse events can occur in people who use the masks, or in people near a person using the mask. The recalled masks have magnets (placements shown by black circles in the picture below) 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. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) 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.

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