FDA Issues Class I Recall for Magnet ResMed CPAP Masks
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ResMed Ltd, a prominent CPAP manufacturer, is warning users of specific respiratory masks equipped with magnets about the potential for injury or death while using those devices.
ResMed’s AirFit and AirTouch masks contain magnets that could potentially interfere with implanted metallic medical devices and objects in the body and cause serious harm, according to the U.S. Food and Drug Administration. The agency labeled the warning as a Class I recall.
“The recalled masks have magnets that can cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices or metallic objects in the body,” the FDA wrote in a statement. “Potential adverse events can occur in people who use a recalled ResMed mask with magnets or in people near a person using the mask.”
At least six injuries were reported that required medical intervention or hospitalization; however, no deaths have occurred, the FDA reported.
According to the FDA, the magnets could impact the patient, their bed partner or a caregiver who has a metallic medical device such as a pacemaker, implantable cardioverter defibrillator, neurostimulator, aneurysm clip, ocular implant, dental implant or mental splinter in the eye or metal shrapnel in the body.
The health agency noted that this recall is considered a correction and not a removal of the product from the market.
ResMed Mask Recall Information
ResMed announced the recall in January, impacting more than 20 million masks in the U.S. that were distributed from January 2020 through November 2023. The masks are intended to be used by people who have been prescribed non-invasive positive airway pressure (PAP) therapy, such as CPAP or bi-level therapy.
The masks can be used with other manufacturers’ CPAP and BiPAP machines.
The affected devices include:
- 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
To see a full list of masks with details, please go to the FDA’s ResMed recall webpage.
Users should switch to a non-magnetic mask if they, or a caregiver or bed partner, have implanted medical devices or metallic objects in the body. The magnetic mask should be kept at least six inches away from the metallic device. Contact a health care provider for advice to determine if another mask can be used.
The mask may continue to be used if the wearer and others in close physical contact do not have any metallic devices.
“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.”
New Recall Is Latest in Series of CPAP Issues
ResMed’s recall is the latest in a series of CPAP (Continuous Positive Airway Pressure) issues that have impacted the industry.
Philips Respironics, another prominent CPAP manufacturer, has faced its share of challenges leading to the recall of millions of faulty CPAP devices. The company issued a recall in June 2021 because the PE-PUR polyurethane foam used for sound abatement could fail in certain environments.
The foam could release tiny particles and gasses that could cause serious health consequences, including cancer, inflammatory disease and severe respiratory illnesses.
The FDA has received more than 300 death reports and over 98,000 medical device reports linked to the recalled machines.
As of January 2024, Philips faces 755 CPAP lawsuits as part of a multidistrict litigation case in Pennsylvania. Trials could begin as early as 2024. Lawyers are actively taking Philips CPAP lawsuit clients.
Philips recently settled a class action lawsuit for $479 million to cover recalled devices sold in the U.S. from 2008 to 2021. This is separate from the MDL.