Devices

Philips Respironics Recalls 17 Million Airway Masks

Philips Respironics has recalled 17 million masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern related to magnets that connect components to hold the device in place. “The magnets can potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask, such as a bed partner, who have such devices,” an agency recall notice says. “Medical devices that could potentially be affected by these magnets include brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators, ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants or any metallic implanted medical device affected by magnets.”

The agency says five mask types are affected by the recall — DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks. To date, the company has reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks. Additionally, FDA is providing recommendations in a safety communication for patients, caregivers and health care providers concerning use of the recalled masks with magnets.

This is the latest issue involving ongoing safety concerns and numerous recalls involving the airway devices. Recently, Philips acknowledged it was negotiating a consent decree with the Department of Justice (DoJ) acting for FDA over GMP issues with its troubled Respironics unit and related devices (see earlier story). Earlier this year, FDA issued a rare Section 518(a) notification order (see story) to Philips requiring it to notify patients and others of the company’s 6/14/2021 recall of the ventilators, CPAP and BiPAP machines, and the “unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane sound abatement foam used in those products.” The notification order was necessary due to what the agency described as “inadequate” company notification efforts to date.

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