Philips CPAP Masks Recalled Due to Risk Magnets May Interfere with Implants, Causing Serious Injury or Death

The recalled Philips CPAP masks have magnets which that may cause problems for heart devices and other medical implants, the FDA warns

Philips is recalling more than 17 million BiPAP and CPAP machine masks, following reports of problems where magnets in the breathing machine face masks interfered with pacemakers, defibrillators, stents and other implanted medical devices, posing a risk of serious injury or death for users.

The U.S. Food and Drug Administration (FDA) announced the Philips CPAP mask recall on September 6, indicating that several models of full face masks and nasal masks contain magnetic headgear clips to hold them in place, which may disrupt the functionality of critical medical devices in users, or those nearby.

The recalled Philips masks are used with bilevel positive airway pressure (BiPAP) machines and continuous positive airway pressure (CPAP) machines, which are commonly worn by individuals suffering from sleep apnea or other respiratory conditions, but in homes and hospital settings.

Philips CPAP Mask Magnetic Interference Poses Serious Risk

As of August 30, 2022, the FDA indicates it has identified at least 14 serious injuries linked to the Philips CPAP mask magnets, including incidents that resulted in a pacemaker failure, a need for shunt adjustment, resetting of automatic implantable cardioverter defibrillators, arrhythmia, cognitive changes, headaches, change in heartrate (tachycardia, bradycardia), convulsions (seizures), and irregular blood pressure.

“The recalled masks have magnets that can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted metallic medical devices or metallic objects in the body”, the FDA warned in the recall announcement.

Three out of the five recalled Philips masks are designed for patients that weigh more than 66lbs, while the recalled Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP is designed for patients seven years of age and older weighing more than 40lbs. Specific models of Philips BiPAP and CPAP masks impacted by the recall include;

• Amara View Full Face Mask
• DreamWisp Nasal Mask
• DreamWear Full Face Mask
• Wisp and Wisp Youth Nasal Mask (40lbs or more)
• Therapy Mask 3100 NC/SP (40lbs or more)

The FDA warns the magnets can affect the functioning or induce movement of implanted metallic devices or metal devices in the body such as shrapnel or splinters in their eyes.

Those with life-saving implanted metallic devices are being warned of the potential risk of injury the magnets could cause, which include:

• Cerebral spinal fluid and ventriculoperitoneal shunts: potential increased pressure on the eye or brain, which may be fatal.
• Aneurysm clips: disrupted suture lines or clip separation, which may be fatal.
• Pacemakers: heart block or irregular heartbeat, which may be fatal.
• Cardioverter defibrillators: may fail to shock, which may be fatal.
• Neurostimulators: compression of the brain, seizures, or lead migration, which may be fatal.

The FDA is encouraging patients, or those that closely interact with patients, who have implanted metallic medical devices or metallic objects in the body, to stop using the recalled mask and switch to a non-magnetic mask, if available. Consumers should keep the mask at least six inches away from metallic devices at all times and while you consult with your healthcare provider to determine if another mask can be used for either bilevel positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP) treatment.

Millions of Previously Recalled Philips CPAP Machines Impacted

The problems with Philips CPAP masks impact many of the same consumers who have already had their CPAP machine recalled, due to a defective sound abatement phone that was used in millions of machines sold between 2009 and April 2021.

A massive Philips CPAP recall was issued in July 2021, for devices that contained a polyester-based polyurethane (PE-PUR) foam that was intended to reduce noise and vibrations from the machine when used while sleeping. However, the foam has been found to degrade and release toxic particles and gasses directly into the machine’s air patheways and the face masks of users.

Thousands of Philips CPAP lawsuits are already being pursued users who indicate that they developed various types of cancer, organ damage and respiratory problems after breathing the toxic particles through their CPAP mask.

The FDA has been very critical of Philips handling of the CPAP recall, indicating that the company failed to properly address problems and did not take sufficient steps to make consumers aware of the serious health risks associated with the continued use of the machines, indicating earlier this year that it would require a new plan from Philips for handling the CPAP machine recall, including a requirement to refund, repair or replace devices.

Since the first recall, the FDA has received more than 69,000 reports of problems from the Philips CPAP foam, including at least 168 deaths.

Reported Philips CPAP symptoms linked to the PE-PUR foam have ranged widely, including pneumonia, asthma, infections, headaches, coughing, dyspnea, dizziness, chest pain and other respiratory symptoms. It is also believed that the FDA’s review of these reports led to the discovery that Philips CPAP machine masks were also interfering with implanted medical devices.

Just last week, the company announced a separate BiPAP machine recall, impacting hundreds of A-Series BiPAP A30 (Ventilator), A-Series BiPAP A40 (Ventilator), A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ models, which are equipped with a non-compatible material that also may release volatile organic compounds (VOCs) directly into the machine’s air pathways.

Prior to this new Philips CPAP mask recall, the company already faced what some estimates suggest will be billions in liability for problems associated with their products. In the federal court system, the U.S. District Judge presiding over the litigation has appointed a special master to oversee negotiations between parties in an attempt to reach Philips CPAP settlements to resolve thousands of claims working their way through the court system.