17 million CPAP masks recalled for ‘serious’ safety issue involving magnets

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The US Food and Drug Administration (FDA) has recalled millions of continuous positive airway pressure (CPAP) masks due to “serious safety concerns”.

According to the FDAthe approximately 17 million recalled Philips Respironics CPAP or bi-level positive pressure masks “have magnets…and may cause potential injury or death when use of a recalled mask with magnets interferes with certain implanted metal medical devices and metallic objects in the body.”

The recalled devices include:

  • Amara View full face mask
  • DreamWisp nasal mask
  • DreamWear Full Face Mask
  • Wisp and Wisp Youth Nasal Mask
  • Therapeutic mask 3100 NC/SP

As of August 30, 2022, Philips has reported 14 serious injuries and no fatalities resulting from the use of the masks.

The FDA says CPAP masks can endanger the mask user or even people who are near the mask user.

The FDA lists the types of metallic metal devices that could negatively interact with the recalled CPAP masks, resulting in injury or death:

  • Pacemakers
  • Implantable cardioverter defibrillators
  • Metal stents (such as aneurysm, coronary, tracheobronchial, and biliary)
  • Neurostimulators (such as hypoglossal nerve stimulators)
  • Magnetic metal implants, electrodes and valves placed in the upper limbs, torso, neck or head
  • Cerebrospinal fluid shunts (such as the ventriculoperitoneal shunt)
  • Aneurysm staples
  • Embolic coils
  • Intravascular Flow Disruption Devices for Intracranial Aneurysm
  • Metal skull 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 containing metal
  • Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing aids, and brainstem hearing implants)
  • Magnetic Denture Attachments
  • Implantable ports and pumps (such as insulin pumps)
  • Metal gastrointestinal clips
  • Certain metal joint prostheses
  • Devices labeled as magnetic resonance (MR) hazardous
  • Magnetic metal implants not labeled for MR or not assessed for safety in a magnetic field
  • Metallic flashes in the eyes
  • metallic shine in the body

Potential risks of CPAP masks interfering with metal/medical devices inside the body include:

  • For cerebrospinal fluid and ventriculoperitoneal shunts: potential increase in pressure on the eye or brain, which may be fatal.
  • For aneurysm clips: broken suture lines or clip separation, which can be fatal.
  • For pacemakers: heart block or irregular heartbeat, which can be fatal.
  • For automatic defibrillators: may not produce a shock, which may be fatal.
  • For neurostimulators: brain compression, convulsions or lead migration, which can be fatal.

The FDA says users can continue to use the recalled mask, as long as the user and those around the user do not have any of the implanted metallic medical devices or metallic objects in the body listed above that could be affected by the magnets in the masks.

If you have any questions about the recall, you can contact the Philips Customer Care Solutions Center at 1-800-345-6443 or visit their website at www.usa.philips.com.

In June 2021, Philips recalled three to four million CPAP devices due to possible health risks associated with sound-absorbing polyester-based polyurethane foam used in the devices.

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