The U.S. Food and Drug Administration (FDA) has released one of the largest recalls of Philips Respironics continuous positive air pressure (CPAP) machines. The September 6 announcement recalled more than 17 million devices due to possible injury or death.
CPAP machines and their related devices, bilevel positive airway pressure (BiPAP) machines, are medical tools designed to assist patients who are living with obstructive sleep apnea, respiratory insufficiency, or respiratory failure. These devices maintain breathing patterns overnight or during periods of time when breathing stops.
According to the FDA, five CPAP and BiPAP masks have been recalled: the Amara View, DreamWear, DreamWisp, Wisp, and Wisp Youth masks. These devices were recalled because magnets designed to hold the device in place were deemed faulty. These magnets can cause movement of implanted metallic devices and affect the functionality of the device. Some devices that could be impacted by the defective magnets include:
- Aneurysm clips
- Brain stents
- Cochlear implants
- Implanted cardioverter defibrillators
- Insulin pumps
- Magnetic denture attachments
- Neurostimulators used in the neck
- Ocular implants
- Pacemakers
- Ventriculoperitoneal shunts
These magnets can cause injury or death when they interact with any of these devices. Additionally, the FDA has clarified that not only are CPAP device users at risk, but any bed partners are also at risk.
Currently, Philips has reported 14 severe injuries including pacemaker failures, cardiac arrhythmia, irregular blood pressure and seizures. The Director of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D., stated, “This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices.”
Director Shuren’s comments are referring to previous recalls of Philips products in 2021 and 2022. These previous recalls were based on other defects such as the degradation of polyester-based polyurethane (PE-PUR) foam, or faulty adhesive that causes potential power failure. The PE-PUR foam degradation in particular has even led to litigation in the form of a class-action lawsuit. In order to clarify the situation with recalled Philips devices, the FDA has created an FAQ to help consumers.