Another Major Recall for Defective Medical Devices Previously Implicated in Toxic Outgassing
Philips Respironics is part of the Philips international conglomerate better known for its electronics products. Acquired by Philips in 2007, Respironics Inc. was the successful manufacturer of a variety of medical devices, including a series of respiratory ventilator devices. These include “bilevel positive airway pressure” and “continuous positive pressure” devices, known respectively as BiPAP and CPAP masks used not only in hospitals but by millions of home users, as well, primarily for treatment of sleep apnea breathing difficulties. Already subject to a major sleep apnea mask recall in 2021 over concerns of toxic gasses being given off by decaying polyurethane foam in the respirator units, a new recall impacts a number of the company’s masks that use powerful magnets to hold the devices in place due to worries that the magnets may interfere with other medical devices implanted in patients.
What Devices Are Included in the New Sleep Apnea Mask Recall?
While the prior recall over toxic gas worries involved more than 5 million respirator units, the new recall is of some 17 million masks including the following models:
- Wisp Youth
- Amara View
Magnets inside these masks are intended to keep the devices firmly in place while users shift about in their sleep. Unfortunately, those magnets are powerful enough to raise significant concerns that they may interfere with other implanted, potentially lifesaving medical devices such as pacemakers, brain stents, neurostimulators, and cardiac defibrillators. These dangers are significant enough that the United States Food and Drug Administration (FDA) has issued a Class I recall. The notice includes a lengthy list of implanted devices or objects inside the body that could cause injury or death due to interaction with the mask magnets. In addition to the devices already listed, these include:
- Metallic aneurysm and coronary stents
- Implanted electrodes
- Implanted valves with metallic components
- Some ocular implants for glaucoma and retinal problems
- Some contact lenses
- Cochlear and other auditory implants
- Insulin pumps
- Some joint replacements with metal parts
- Devices labeled as unsafe in magnetic resonance imaging (MRI) scanners
- Metallic splinters or shrapnel objects in the body
The FDA reported that fourteen serious injuries had already been reported related to these devices, and with more than 17 million having been manufactured and sold, the scope of problem is very significant.
Just More Problems for Philips After Prior Recall
The problems in Philips sleep apnea and respirator devices that led to the recall of more than five million units in 2021 wasn’t specifically in the masks, but rather in the respirator hardware itself. These machines that pump air into the masks were manufactured containing polyurethane foam that was primarily used to make the machines quieter when in operation. Unfortunately, it was found that this foam was degrading over time and releasing toxic chemicals including dimethyl diazine (azomethane) and phenol (carbolic acid).
Concerns raised by this decaying foam included the possibility of chemical burns from phenol, cancers of the liver and kidneys from the azomethane, and mesotheliomas (similar to those from asbestos inhalation) from the small particulate matter.
What Should Users Do?
The 2022 sleep apnea mask recall instructs users to cease using the magnetic mask models and switch to a non-magnetic mask if the users or anyone near them have any of the listed medical implants or other metallic items in their bodies, as well as to follow up with their medical providers for other therapy options. The earlier 2021 recall for respiratory devices with toxic outgassing advised completely discontinuing use of the impacted respirators and followup with users’ doctors for replacement devices or other treatment.
View this recent news video reporting on the earlier Philips device problems and recall:
Sacramento Defective Medical Device Lawyer
Hello, my name is Ed Smith, and I’m a Sacramento Defective Medical Device Lawyer. Millions of people every year are successfully helped by life-improving — and sometimes life-saving — medical devices. Unfortunately, some medical devices are not as well designed and manufactured as they ought to be, and this can lead to significant dangers to the people who use them. If you or a member of your family has been seriously injured by a defective medical device, such as the currently recalled sleep apnea masks with magnets or the previously recalled sleep apnea units with potential for toxic outgassing, please contact us at (916) 921-6400 or (800) 404-5400 for free, friendly advice. You can also reach us through our online contact form.
Image by Gerd Altmann from Pixabay
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