The U.S. Food and Drug Administration (FDA) has announced a recall of Philips Respironics Positive Airway Pressure (CPAP/Bi-PAP) masks with magnetic closures. The magnets in the recalled masks may affect certain metallic medical devices or metallic objects in the body, presenting a potential risk. Masks with magnets made by other companies are not included in the recall.
“We want to ensure that any Veteran using one of the Philips CPAP or Bi-PAP masks with magnetic closures does not have an implanted medical device that can be impacted by magnets,” said Dr. Charles Atwood, VHA acting national program director for Sleep Medicine. “This warning is extended to anyone in close proximity when the mask is in use, such as bed partners.”
Magnet closure concerns
The magnetic closures for these masks can cause implanted medical devices to malfunction if they are within six inches of implanted metallic medical devices. These implanted medical devices can include pacemakers, implantable cardioverter defibrillators, neurostimulators, magnetic metallic implants/electrodes/valves (placed in upper limbs, torso, or higher), cerebral spinal fluid shunts (e.g., ventriculo peritoneal shunt), embolic coils, magnetic denture attachments, certain magnetic metallic implants and others. A list of devices that may be impacted is on the FDA website.
If you have a mask with magnets and are concerned about interference with implanted devices, the magnets can be removed, and the Velcro strap will fit through the empty magnet space. You can contact your care provider to order plastic replacement clips or a different mask.
The masks included in the recall are Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, and the Therapy Mask 3100 NC/SP. VA has a hold on distributing these masks until updated warning labels are added or care providers confirm that the Veteran does not have one of the implanted devices noted in the recall.
This issue impacts patients nationwide with an implanted device who wear Philips masks with a magnetic closure, including their partners and other loved ones who are within close proximity while the mask is in use. VA is working to contact patients who have been issued the affected Philips Respironics masks by a VA provider.
If you have an implanted magnetic medical device and use a Philips Respironics CPAP or Bi-PAP mask with a magnet, contact your care team for a replacement. Veterans who have general issues or concerns can contact the Philips Customer Care Solutions Center at +1-800-345-6443.