ResMed Recall: CPAP Masks Interfere With Life-Saving Implants and Devices

Recently, the FDA issued a recall for 20 million ResMed CPAP masks. They were recalled because the mask’s magnetic clasp can sometimes interfere with the function of certain life-saving implants and devices, potentially causing serious injury and death.

This Class 1 recall, the most serious type of FDA product recall, affects all AirFit or AirTouch CPAP masks manufactured by ResMed.

Here’s what you need to know about this recall process and how the experienced attorneys at Sommers Schwartz can help if this product has injured you.

What Is a CPAP Machine?

CPAP stands for “continuous positive airway pressure,” and the machine is designed to help treat sleep apnea.

Sleep apnea is a potentially serious medical condition marked by irregular breathing. People with this condition often stop breathing while they sleep due to either an obstructed airway or a disrupted neurological pathway in the brain. In both scenarios, the lack of oxygen eventually triggers the patient’s survival instinct to breathe; however, it disrupts the sleep cycle every time it does.

Episodes of sleep apnea can occur hundreds of times each night, putting patients with this condition at a much higher risk for many serious medical concerns, including: 

• High blood pressure.
• Diabetes.
• Metabolic syndrome.
• Stroke.
• Heart disease.
• Stroke.

A CPAP machine helps prevent sleep disruptions by providing patients with  continuous oxygen flow throughout the night. These machines correct sleep apnea exceedingly well—in fact, some claim that CPAP machines are 100% effective when used correctly.

However, for those using a ResMed AirFit or AirTouch mask, the benefits of this machine might no longer outweigh the risks of going without.

What’s Wrong With ResMed Masks?

The problem with ResMed’s CPAP mask centers around how it attaches to the headgear.

While many CPAP masks are secured using uncomfortable hooks and buckles, the AirFit and AirTouch models attach to the headgear using small, magnetic buttons. These simple, lightweight clasps are convenient to use and lay comfortably against a patient’s jaw when worn properly.

Unfortunately, this magnetic design can also interfere with implants and essential life-saving devices, including:

• Pacemakers.
• Implantable cardioverter defibrillators (ICD).
• Neurostimulators.
• Cerebrospinal fluid (CSF) shunts.
• Insulin pumps.
• Aneurysm clips.
• Heart valves.
• Electrodes.
• Hearing implants.
• Ocular implants.

Prior to this recall, ResMed’s warning label cautioned patients to keep the magnetic clasps at least two inches away from implants or medical devices; however, the FDA determined this distance was inadequate. The recall will address these safety concerns and update warnings to reflect the current risks.

Which Masks Are Recalled?

Not all of ResMed’s CPAP masks fall under the recall. This notice applies only to AirFit and AirTouch models with magnetic clasps sold between January 2020 and November 2023.

For concerns about other CPAP designs and brands, review the complete list of product recalls on the US Consumer Product Safety Commission’s website.

Does a Recall Mean I’ll Be Compensated?

A product recall doesn’t guarantee you’ll be compensated. In some cases, a recall can validate your claim and reinforce your argument that the manufacturer knew their product was defective. Timing is important, though, and the success of your claim could depend on when you were warned and whether you suffered a foreseeable injury.

So far, the magnetic clasp in ResMed’s CPAP design hasn’t killed anyone, but that doesn’t mean it’s safe. Patients using this product should exercise extreme caution and contact an attorney immediately about any injuries stemming from its use.

Did a ResMed CPAP Mask Injure You?

A magnetic clasp is a clever, convenient design for some frequent CPAP users. But convenience shouldn’t come at the expense of personal safety.

If your CPAP mask has magnetically interfered with one of your life-saving devices, you may be entitled to compensation. Contact Sommers Schwartz today for a free consultation and let our team of highly experienced personal injury attorneys defend your rights and interests during this important process.