The devicemaker recalled five types of their BiPAP and CPAP masks after 43 complaints, including 14 serious injuries, were reported. The recall is classified as class 1, the most serious type, because the product’s magnets can interfere with implanted metal medical devices — such as pacemakers — and “can potentially cause injury or death,” according to the FDA.
In the first statement about the recall, the FDA said the serious injury reports included “pacemaker failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks.” No deaths have been reported.
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