Dive Brief:
- Interference between magnets in certain Resmed masks and other medical devices is implicated in six injuries, according to the U.S. Food and Drug Administration.
- The FDA shared the information in a notice reiterating that Resmed is doing a product correction and the agency has categorized the action as a Class I recall.
- Resmed contacted customers in November after determining that magnets in its positive airway pressure therapy masks should be kept away from active implants and metallic medical devices.
Dive Insight:
Resmed alerted customers in November to changes to the instructions for use of its magnetized masks. At that time, the medtech company said no permanent injuries or deaths had been reported in relation to interference between its masks and medical devices such as pacemakers and valves.
The potential for the magnets to cause serious injury or death led the FDA to assign the product correction to Class I, the most serious type of recall. The agency added the correction to its recall database in December.
On Thursday, the FDA published a statement about the correction of more than 20 million Resmed masks sold in the U.S from January 2020 to November 2023. The statement links to Class I database entries that the FDA published in December and reiterates the messages that Resmed shared in its urgent field safety notice, such as the need to keep magnets six inches away from medical devices that could be affected by interference.
Six injuries and no deaths were reported in the FDA’s latest notice. The notice lacks further information about the nature of the reported injuries.
An earlier correction of 17 million magnetized masks from Resmed’s rival Philips was linked to 14 serious injuries including pacemaker failure, arrhythmia, seizures and irregular blood pressure.
