According to the FDA, ResMed Ltd. has issued a Class I recall of its AirFit and AirTouch Continuous Positive Airway Pressure (CPAP) masks with magnets because the products may magnetically interfere with other medical devices.
Indicated as non-continuous ventilatory devices, AirFit and AirTouch masks are designed for use by patients who weigh over 66 pounds and who are under prescription for non-invasive positive airway pressure (PAP) therapy, like CPAP or bi-level therapy. The products are typically re-used by an individual in a home setting, or by several patients in a hospital setting. Magnets are affixed to the CPAP masks’ lower headgear straps and frame connections in order to make the mask more comfortable.
While the existing product label warns users to keep magnets at least 2 inches apart from other medical devices that may be affected, officials acknowledge that the instruction does not provide a list of specific devices that could be adversely influenced. Because the magnet’s close proximity to certain medical implants and devices could potentially disrupt their function, use of the product poses a risk of serious harm, or even death, to some users.
ResMed’s recall was initiated on November 20, 2023 and covers 20,414,357 AirFit and AirTouch masks that were distributed in the U.S. between January 2020 and November 20, 2023. Affected model numbers are as follows: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i.
Following a review of the possible risks posed by the magnet features, officials are making plans to update the product labels with additional warnings and guidance to encourage safe usage of the masks by patients and healthcare professionals.
Both patients and healthcare providers are warned that affected masks could potentially cause major adverse health outcomes, including death. While no deaths have been reported to date, the company has received six reports of related injuries.
An “Important Medical Device Advisory” sent to affected ResMed customers on November 20, 2023 made the following requests:
- Maintain at least a six-inch distance between the magnets and any implants or medical devices whose function may be impacted by magnetic interference.
- Patients are advised to contact their physician or the implant/device manufacturer to confirm how their devices could be adversely impacted by magnetic interference.
- Review the detailed information and recent updates included in the “contraindications and warning labels” on the ResMed Magnet Update website.
U.S. customers can direct recall-related questions to ResMed at 1-800-424-0737.
As the FDA continues to oversee this recall, healthcare professionals and consumers are urged to report any adverse events or quality issues to the agency’s MedWatch program.
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