ResMed’s CPAP mask recall tagged as Class I by FDA

The US Food and Drug Administration (FDA) has tagged ResMed’s recall of its magnet-containing Continuous Positive Airway Pressure (CPAP) masks as a Class I recall.

Class I recalls are designated as having the potential for serious injuries or death if devices continue to be used.

In November 2023, ResMed issued a field safety notice after discovering that the magnets in the masks could interfere with medical implants. In December 2023, the US-headquartered company went further and conducted a field correction.

The recall, which in this case is a correction as opposed to a product removal, affects over 20 million of ResMed’s AirFit and AirTouch masks in the US, according to a 12 January FDA notice.

There have been six reported injuries and no deaths, according to the FDA.

Shares in ResMed were 2.6% down at market close compared to market open on 12 January.

The masks are indicated for use in people who weigh at least 66 pounds and who have been prescribed non-invasive positive airway pressure. This includes CPAP or bi-level therapy, for use either in-hospital or at-home.

The masks use magnets to provide easier attachment and detachment to headgear. The company says this use is especially important to patients with dexterity vision impairment, or those with disabilities.

The recall arose  due to reports of magnetic interference of the magnets with implanted devices in the patient. ResMed said that the medical device function could be affected, whilst ferromagnetic implants could change position because of mask magnet proximity.

Active medical implants that could be affected include cardiovascular devices such as pacemakers, and implantable cardioverter defibrillators (ICD). Neurostimulators and cerebrospinal fluid (CSF) shunts can also suffer from interference, along with diabetes devices such as insulin/infusion pumps.

The FDA said that ResMed is recalling the devices to update labels, add additional warnings, and provide information to those who use the masks. This includes rules to keep the magnets at least six inches from implants or devices that could be affected.

Issues with magnets in masks has not been restricted to ResMed. Philips, which has battled large recalls across its respiratory medical devices, alerted customers to safety issues of its continuous PAP or bi-Level PAP therapy masks after reports highlighted similar issues of its mask magnets affecting implanted devices.

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• Source: https://www.medicaldevice-network.com/news/resmeds-cpap-mask-recall-tagged-as-class-i-by-fda/