Philips Respironics has recalled certain CPAP and BiPAP masks containing magnets that may cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices and metallic objects in the body, according to an FDA alert.
According to the FDA, these potential adverse events can occur in people who use the masks, or in people near a person using the mask.
As of August 30, 2022, Philips reported 14 serious injuries and 0 deaths related to the use of the recalled masks, the FDA says. According to the agency, the reported injuries included pacemaker failure leading to pacemaker replacement, a need for shunt adjustment, resetting of automatic implantable cardioverter defibrillator, arrhythmia, cognitive changes, headaches, change in heartrate (tachycardia, bradycardia), convulsions (seizures), and irregular blood pressure.
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 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 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).
- Figure 1: Amara View Full Face Mask
- Figure 2: DreamWisp Nasal Mask
- Figure 3: DreamWear Full Face Mask
- Figure 4: Wisp and Wisp Youth Nasal Mask
- Figure 5: Therapy Mask 3100 NC/SP
- (black circles indicate magnet placement)
According to the FDA, 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:
- Implantable cardioverter defibrillators
- Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
- Neurostimulators (such as hypoglossal nerve stimulators)
- Magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head
- Cerebral spinal fluid shunts (such as ventriculoperitoneal shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Ocular implants (such as glaucoma implants and retinal implants; intraocular lenses placed during cataract surgery are not impacted)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Implantable ports and pumps (such as insulin pumps)
- Metallic gastrointestinal clips
- Certain metallic joint replacements
- Devices labeled as Magnetic Resonance (MR) Unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
- Metallic splinters in the eye
- Metallic shrapnel in the body
The FDA reports that, if the magnets affect the functioning or induce movement of certain medical devices, the potential risks may include:
- For cerebral spinal fluid and ventriculoperitoneal shunts: potential increased pressure on the eye or brain, which may be fatal.
- For aneurysm clips: disrupted suture lines or clip separation, which may be fatal.
- For pacemakers: heart block or irregular heartbeat, which may be fatal.
- For cardioverter defibrillators: may fail to shock, which may be fatal.
- For neurostimulators: compression of the brain, seizures, or lead migration, which may be fatal.
The FDA recommends healthcare providers:
- Tell patients to stop use of the recalled mask and switch to a non-magnetic mask if available, if they or someone near them when using a recalled mask have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.
- Ensure the recalled mask is kept at least 6 inches away from metallic medical implants, metallic objects in the body, or medical devices that can be impacted by the magnetic fields.
- Properly dispose of the recalled mask.
- Discuss the health risks associated with using the recalled masks with patients who may be at risk for potential injury or death due to magnets affecting the function or inducing movement of certain implanted metallic medical devices or metallic objects in the body.
- Do not prescribe use of the recalled masks on patients who have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks. Prescribers should also ask about any other people who may be at risk for injury or death if they are near a recalled mask while it is being used.
- If you have any problems with a recalled mask or if you treat a patient who has been affected, report the issue through the FDA’s MedWatch Voluntary Reporting Form.