Last year, CPAP device manufacturer Philips Respironics made headlines with a major recall of many of its CPAP machines. With that recall still ongoing, the company has recently issued a new voluntary recall, this time affecting some of its CPAP masks.
While the current recall is voluntary, it still has the potential to affect millions of people who use these devices for their sleep apnea therapy. As one of the industry’s biggest brands, here is what you should be aware of if you’ve purchased a Philips Respironics CPAP mask through Help Medical Supplies.
Which Masks Are Getting Recalled?
The recall affects five types of CPAP masks, which are being recalled because of their use of magnetic clips. According to the manufacturer, “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.”
The masks included in the recall are the Amara View Full Face Mask, the DreamWisp Nasal Mask, the DreamWear Full Face Mask, the Wisp Nasal Mask (this also includes the Wisp Youth Nasal Mask), and the Therapy Mask 3100 NC/SP.
The magnetic clips have been determined to have the potential to cause severe injury or even death to users or people around them if those individuals have an implanted medical device or implanted metallic object. While no deaths have been reported, the potential risk has been acknowledged as part of the recall warning.
The list of medical devices that could be negatively impacted by the magnetic clips is wide ranging, and includes pacemakers, metallic stents, neurostimulators, aneurysm clips, ocular implants, cochlear implants, metallic gastrointestinal clips, and more.
Should I Stop Using My Mask?
While the scope of the recall may seem alarming, it is important to distinguish that this is a voluntary recall. The masks pose no danger to individuals who don’t have a metallic implanted device themselves. If no one in your household has a device that could be negatively impacted by the clips, you can continue to use the mask as normal.
Because of this, Philips Respironics plans to continue producing and selling the affected masks. However, new masks will include updated labels and warning guidance so that individuals are aware of the potential risk. Devices listed in the recall are contraindicated for use of these masks — meaning that if you or a household member uses one of those medical devices, you should stop using these masks.
The manufacturer also advises that the CPAP masks be kept at least six inches away from other medical implants and devices to prevent interference from the clip’s magnetic field.
If you or a household member could be harmed by the magnetic clips, consult with your doctor. They will help you determine whether you should stop use of the mask immediately, or if it’s okay to continue using it until you can purchase a replacement.
As a Healthline article covering the recall explains, “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.”
I’m Affected By the Recall. What Should I Do?
If you own one of the affected masks and have questions about the recall, Philips Respironics recommends that you contact their customer service department at 1-800-345-6443, which is available from 8:30 AM to 8 PM EST, Monday through Friday. Individuals who have experienced any medical issues related to the mask are also encouraged to report the incident to the FDA at 1-800-FDA-1088 or online.
Philips Respironic’s recall statement says that it plans to help patients who need to replace their mask obtain one that does not use magnetic clips. That being said, there are over 17 million masks that have been affected by this recall. Backorders and the sheer volume of the recall could cause it to be quite some time before Philips can provide a replacement mask directly.
In this scenario, the best solution is to contact both Philips Respironics and your doctor. Your doctor can help you make an informed decision about whether it is safe for you to continue using the recalled mask until a replacement arrives. Depending on your situation, you may need to order a replacement from Help Medical Supplies.
After you get a replacement, you should dispose of the old mask.
Find a Replacement With Help Medical Supplies
If you need to replace your CPAP mask immediately as a result of this current recall, finding a suitable replacement shouldn’t become a major source of stress. Help Medical Supplies can make it easy.
With a wide range of CPAP masks available at discounted prices off of MSRP, you can find a suitable replacement at a price you can afford. Fast and free shipping is available for all orders $89 and up, so you can get a new mask that will allow you to get the quality sleep you need.