FDA Issues Warning on ResMed CPAP Masks: Safety Alert for Users
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The U.S. Food and Drug Administration issued a serious warning for users of certain ResMed Ltd.’s magnetic sleep apnea CPAP masks, cautioning the device could cause severe injury or death.
ResMed’s AirFit and AirTouch masks’ magnetic clips that hold the mask strap to the head frame could interfere with certain implanted metallic medical devices or metallic objects in the body, according to the FDA, which labeled the warning as a Class I recall, the most serious issued by the agency.
Users of these devices, as well as health care professionals and caregivers, should be cautious if they have an implanted device such as a pacemaker, implantable cardioverter defibrillator, aneurysm clip and other devices.
The magnet could cause those devices to stop working properly or cause movement resulting in injury or death. Six injuries have been reported to the FDA, related to the use of the recalled masks. There have been no reports of death.
“The injury reports involved magnetic interference with implanted devices resulting in allegations of serious harm that required medical intervention or hospitalization,” the FDA stated. “The reported devices include an implantable cardioverter defibrillator, a cochlear implant, a cerebrospinal fluid shunt, and brain and dental implants.”
Which ResMed Masks are Impacted?
ResMed states that roughly 20 million masks are impacted by the recall that were distributed in the U.S. from January 2020 through November 2023. The masks are prescribed to help people with sleep apnea breathe while sleeping.
ResMed masks impacted by the recall are listed below and more detailed information can be found on the FDA’s ResMed mask recall webpage.
Full face masks:
- AirFit F20
- AirFit F20 for Her
- AirTouch F20
- AirTouch F20 for Her
- AirFit F30
- AirFit F30i
Nasal masks:
- AirFit N10
- AirFit N10 for Her
- AirFit N20
- AirFit N20 for Her
- AirTouch N20
- AirTouch N20 for Her
Non vented mask:
- AirFit F20 NV
Users should switch to a non-magnetic mask if they, a caretaker or others with close physical contact with the mask, have implanted metallic medical devices. The mask should be kept at least six inches away from the devices.
The mask can continue to be used if the user does not have a metallic medical device. FDA officials noted the recall is considered a correction, not a product removal from the market.
“Patient safety is ResMed’s top priority, and we will always follow our guiding principles that prioritize patient needs and safety to ensure the best care is given to the millions of people we serve worldwide,” ResMed wrote in a statement about the magnet clips.
“To provide patients and health care professionals with updated guidance on the safe use of ResMed masks with magnets, we have updated the contraindications and warnings sections in our user guides.”
Ongoing Challenges in the CPAP Industry
ResMed’s recent recall is part of a string of issues affecting the CPAP industry.
Philips Respironics, a large manufacturer in the CPAP industry, recalled millions of devices in 2021 after PE-PUR sound abatement foam could degrade under certain conditions. The degradation could release small particles and gasses, posing severe health risks to the user including serious respiratory conditions and cancer.
The FDA has linked more than 300 deaths and over 98,000 medical device reports to the Philips recalled units.
As of January 2024, Philips is facing 755 lawsuits consolidated in multidistrict litigation in Pennsylvania, with trials possibly starting in 2024.
Attorneys continue to accept clients for Philips CPAP lawsuits.
Recently, Philips settled a class action lawsuit for $479 million, addressing restitution for devices sold in the U.S. from 2008 to 2021, separate from the ongoing MDL.
