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.
Veteran outreach
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.
Topics in this story
More Stories
Discover the power of your breath! Explore how mindful breathing can bring peace, ease your mind and enhance clarity in this week's #LiveWholeHealth video.
A unique program at Boston VA uses the principles of trauma-informed care to serve homeless Veterans with empathy and understanding.
These outreach opportunities and experiences are tailored to the unique needs of the Veteran community.
I have AIRFIT, full face mask. The mask has straps with magnets. I want to know these are recalled.
No, this mask is not part of the recall.
Hi! This won’t answer your questions but I work for a Prosthodontist who treats sleep apnea with an oral device. It is a proven, effective treatment option. We treat many VA patients. Contact your physician to see if it may be another option for you. If it is you can locate a qualified dentist at http://www.aadsm.org.
I have registered my Capp machine late last year, was told it was affected. I have not received a new unit yet and was wondering what was going on with my replacement unit. I do have a pacemaker installed replaced three times since 1997. Could someone tell when or what is going on with my new unit? They told me my device was affected with a filter that comes apart and is inhaled by user. Will I recieve a new unit and if so when. I registered my unit late 2021 and have not heard anything since? Are you even going to do anything..??.???
This blog post is specifically related to the mask recall. If you registered the device as part of the device recall, it will be up to Philips to replace it as VA does not have devices to replace it with at this time.
I have registered my Capp machine late last year, was told it was affected. I have not received a new unit yet and was wondering what was going on with my replacement unit. I do have a pacemaker installed replaced three times since 1997. Could someone tell when or what is going on with my new unit? They told me my device was affected with a filter that comes apart and is inhaled by user. Will I recieve a new unit and if so when. I registered my unit late 2021 and have not heard anything since?
The ResMed masks also use magnets, are thet not as strong or do they also affect users with medical implants?
They are apparently not as strong and therefore are not part of the recall.
What about the other recall for the ones with bad insulation
They were supposed to replace them by the end of the year
I have a ResMed mask with magnets. If you remove the magnets the mask is unusable, where do I go from here? And why is there not a recall on it?
Resmed masks with magnets are not included in the recall so they can continue to be used. The decision on what to recall is based on FDA recommendations in collaboration with the company.
would this include stints in the heart
Yes, Philips and the FDA use the wording: Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
Therefore, heart seems to be included.
I received my Dream nasal in Minneapolis VA a year ago. But I live in the Philippines, What ca. I do?
Michael J Reincke
Dreamwear nasal masks are not affected by this recall.
Great that you announce this. Shame that the chief of Miami Catch Dept
Seems to think this recall doesn’t effect stents. And when I cited this recall he said He did not know what I was talking about. Stents can’t be moved. The Cardiologist has said the same. I had chest pain and swelling during the use of recall mask. Went to ER. They ruled out heart. Now months later because of this?article I called The VA at Miami Hospital.
No one knew about recall. No proactive measures taken for patients using the recall masks and having the medical devices implanted. No follow up on position of stent. Just told in January it was in the same position.
What good is the recall if VA Doctors are unwilling to get the facts right.
What stents were effected? What where the symptoms of these patients? Are any patients using the mask currently or in the past complaining about similar symptoms?
No the VA Chief in charge just said it can’t move and I don’t know what your talking about. He should retire if can’t verify a position of a stent and is not up to date on current recalls effecting his patients.
My CPAP machine was recalled almost two ytears ago and I am still with that machine. Both Phillips and The representative for VA are at the point they will not even accept my calls. If I leave a message, no one ever replies. My machine is now practically unusable but no one with Phillips or VA will even make an attempt to help. My sleep doctor has even called requesting assistance for ne, still no concern.
How am I supposed to know?
I am one of the Phillips recall cpap owners. I have had to use the same mask for 2 years. Thank you very little!
When I called Phillips to get the list of the stents brand that effected patients were using, they told me it was for me to “find” out. FDA doesn’t specifically say which one nor do they forward a list either. Yes, Thanks little Phillips.
My CPAP machine hasn’t been to replace since the recall my doctor said that she was going to order me a new one and I haven’t received it yet and the Magnus won’t bother me because I don’t have anything on me that causes it magnetic problem
I am pleased that the VA published this warning. When suffering from severe nasal congestion I use one of the Resprionics full face masks secured with magnets. Though eligible for limited VA benefits, I get my apnea supplies from a different provider swho has not warned me about the fastners. I do have an electr9nic 8mplant but it is a monitoring device and I do not believe the magnetic clasp would create a problem, but it would have been nice to receive an alert just the same.