On September 6, 2022, Philips Respironics issued a new recall covering five of its CPAP and BiPAP masks. In the wake of last year’s major recall of Philips Respironics devices, it can be understandably stressful learning of yet another recall that could affect your sleep apnea therapy.
As one of the biggest brands in the CPAP industry, many No Insurance Medical Supplies customers have purchased products from Philips Respironics in the past. Here is a breakdown of what is known about this recall and what you should do.
Which Products Are Getting Recalled?
The recent alert is a voluntary recall that affects five types of Philips Respironics CPAP masks: the Amara View Full Face Mask, the DreamWisp Nasal Mask, the DreamWear Full Face Mask, the Wisp Nasal Mask (including the Wisp Youth Nasal Mask), and the Therapy Mask 3100 NC/SP.
The reason for the recall is that it has been learned that the magnetic clips contained within these masks have the potential to interfere with metallic implanted medical devices.
According to the official recall statement: “As of September 2022, Philips Respironics has received 16 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.”
Because of these reports, it is being advised that patients with implanted devices such as pacemakers, neurostimulators, ocular implants, metallic stents, aneurysm clips, embolic coils, and more not use the masks listed in the recall. Interference with such medical devices could prove fatal, though no deaths have been reported in connection with the masks. The magnets in the recalled masks also pose a potential risk to individuals with metallic implanted devices in close proximity to the CPAP mask user.
Can I Keep Using My Mask?
Unlike the recall of Philips Respironics CPAP machines in 2021, this recall is voluntary. If you use these masks and don’t have a metallic implanted medical device, you can continue to use the mask as usual. Keep in mind, however, that the recall notice also advises mask users who have bed partners, caregivers, or other household members with implanted medical devices to stop using the recalled masks.
Because this issue does not universally affect CPAP users, the masks will continue to be produced and sold, but with updated labeling and guidance that warns users of potential interference with implanted metallic devices. Per the new guidelines, Philips Respironics advises that consumers keep the affected masks at least six inches away from metallic medical implants and other medical devices that could be adversely affect by the magnets’ magnetic fields.
If you or a household member uses a pacemaker or other medical device listed in the Philips Respironics recall notice, you should try to obtain a non-magnetic replacement mask. Dispose of the recalled mask once you obtain a replacement.
As with the previous recall, your best course of action is to contact Philips Respironics directly for more information, especially if you need to switch to a non-magnetic mask. Patients have been instructed to call their customer service line at 1-800-345-6443, which is available Monday through Friday from 8:30 AM to 8 PM ET. The company states that it intends to help provide patients who need a replacement mask with a mask that does not use magnetic clips.
The company also recommends that patients consult with their sleep specialist regarding their therapy needs. Depending on the type of metallic medical devices you use and their location, your physician may advise that you continue using the recalled mask until you can obtain a replacement, or they might recommend that you stop use of CPAP therapy until you can obtain a mask without the potentially dangerous magnetic clips.
The “right” response will vary from person to person. In a Heathline article, Dr. Bruce R Tammelin, Director of Mission Sleep Disorders Institute At Providence Mission Hospital in Orange County, California explained, “In cases of moderate to severe sleep apnea, lack of therapy is more dangerous and can result in the return of excessive daytime sleepiness, resulting in accidents, heart rhythm disturbances, elevation in blood pressure and mood issues. […] The patients are asked to contact their sleep physician who reviews the original sleep study to assess the severity, determine if there is a sleep position which is safer, repeat a home study with a positioning cushion and in some cases use supplemental oxygen.”
While Philips Respironics says it will provide replacement masks for patients affected by the voluntary recall, there is no guarantee of how quickly this will occur. Roughly 17 million masks are affected by the recall, and backorders and shipping delays could cause some time to pass before you can receive your replacement.
Ideally, you should contact Philips Respironics and your doctor as soon as possible, and consider ordering a replacement mask from another source.
Get a Replacement From No Insurance Medical Supplies
While many patients can continue using the affected masks, there are many who must now seek out new CPAP masks to protect themselves and others. Fortunately, you aren’t without options.
At No Insurance Medical Supplies, we offer a wide range of CPAP and BiPAP masks — including nasal pillows, nasal masks, and full face masks. Many of our masks are available at discounted prices off of MSRP so you can order your replacement without breaking the bank. Fast shipping will help you get your replacement mask in a timely manner so you can continue to enjoy quality sleep via CPAP therapy.