ResMed’s Magnet-Related Safety Alert Spurs Highest FDA Recall Rating and Urgent User Measures

In a recent development, ResMed, a prominent player in the medical device industry, faces a safety conundrum mirroring a similar issue encountered by its competitor, Philips. Towards the end of November, ResMed issued a safety advisory regarding specific masks utilized in tandem with its CPAP machines. These masks, equipped with magnets, were identified as potential sources of interference with pacemakers, neurostimulators, and other implanted medical devices.

What began as a biztonsagi adatlap notice has now escalated into a comprehensive field correction, garnering the FDA’s highest recall rating due to an escalated risk of injury or, in extreme cases, fatality linked to the implicated devices. The latest data reveals a total of six reported injuries related to this safety concern, a marginal increase from the initial five instances highlighted in ResMed’s initial warning in November. Importantly, there have been no reported fatalities associated with the issue thus far.

The recall pertains to diverse models of ResMed’s AirFit and AirTouch masks, with an astounding 20.4 million units sold exclusively in the United States. Tailored for individuals weighing a minimum of 66 pounds and prescribed either CPAP or BiPAP therapy, these masks incorporate magnets into their headgear straps and frame connections.

 While designed to streamline the attachment and adjustment process, the potent magnets pose a potential risk when in close proximity to specific medical devices, potentially causing malfunctions or physical displacements.

ResMed’s response to the issue diverges from a conventional recall approach. Users contraindicated for ongoing use of the masks are advised to return them to the company, while others are being informed about updates to the masks’ user guides. 

These updates encompass a more exhaustive list of contraindications, specifying various metallic and other medical implants that may interact adversely with the magnets. Users actively utilizing devices susceptible to magnetic interference are encouraged to transition to a magnet-free alternative.

To further mitigate risks, ResMed has updated warnings, underscoring the necessity of maintaining a minimum distance of six inches between magnetic components and medical devices vulnerable to interference. The company urges individuals to consult their healthcare providers or device manufacturers to assess potential adverse reactions to the magnets.

In a missive addressed to patients in November, ResMed emphasized that despite globally distributing “tens of millions of masks with magnets” since 2014, the company has only received a handful of injury reports. Crucially, none of these reports detail permanent injuries or fatalities.

The U.S. Food and Drug Administration (FDA) has classified the recall as the most severe due to the potential for significant injuries or fatalities. ResMed initiated the recall process on November 20, recalling over 20 million devices in the United States. The FDA reports six injuries associated with the devices, with no reported fatalities. The affected devices were distributed between January 2020 and November 20, 2023.