ResMed Ltd. Recalls CPAP Masks with Magnets Over Magnetic Interference Concerns: FDA Issues Class I Recall

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ResMed Ltd. Recalls CPAP Masks with Magnets Over Magnetic Interference Concerns — ResMed Continuous Positive Airway Pressure (CPAP) Masks With Magnets

In a recent development, ResMed Ltd. has initiated a recall of its Continuous Positive Airway Pressure (CPAP) masks with magnets, as identified by the U.S. Food and Drug Administration (FDA) as a Class I recall. This classification signifies the most severe type of recall, indicating that the use of these devices may lead to serious injuries or even death. It’s crucial to note that this recall is considered a correction rather than a complete product removal.

The affected products, namely the AirFit and AirTouch masks, encompass various model numbers including AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, and AirFit F30i. These masks, distributed between January 2020 and November 20, 2023, have been widely used with a staggering 20,414,357 devices recalled in the United States alone.

The AirFit and AirTouch masks are non-continuous ventilatory devices designed for patients weighing more than 66 lbs. who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. These masks are intended for reuse, either by an individual at home or by multiple individuals in hospital settings.

The reason behind the recall lies in the presence of magnets on the lower headgear straps and frame connections of the CPAP masks. While these magnets are intended to enhance the comfort of wearing the mask, they pose a risk of magnetic interference with certain medical devices, especially when in close proximity (less than 2 inches). This interference may disrupt the function or position of affected medical implants and devices, potentially resulting in severe harm or death.

ResMed is recalling these masks to update the labels, providing additional warnings and information to guide patients and healthcare professionals on safe usage when dealing with masks featuring magnets. The decision to recall and update labels follows a thorough review of potential risks associated with magnetic interference and its impact on medical implants.

Notably, there have been six reported injuries related to the use of these affected masks; however, no deaths have been reported at this time.

For those potentially affected, including individuals prescribed AirFit or AirTouch masks for non-invasive positive airway pressure (PAP) therapy or bi-level therapy, as well as healthcare providers utilizing these masks in home-care or hospital settings, ResMed has taken immediate steps. On December 8, 2023, the company issued an Important Medical Device Advisory to all affected customers.

The advisory instructed customers to keep the magnets at a safe distance of six inches (150 mm) away from implants or medical devices susceptible to magnetic interference. Patients have been urged to consult their physician or the manufacturer of their implant or medical device for further information regarding possible negative effects of magnetic fields on their device.

For detailed information on the recent updates made to contraindications and warning labels, affected individuals are encouraged to visit the ResMed Magnet Update website. Additionally, customers in the U.S. with questions about this recall can contact ResMed at 1-800-332-1088. Vigilance and prompt action are emphasized to mitigate potential risks associated with the use of these recalled CPAP masks.