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Philips Respironics announced that it is recalling certain masks used with CPAP and Bi-Level positive airway pressure (Bi-PAP) machines due to a “serious safety concern.”
In total, more than 17 million masks are subject to the recall.
According to the FDA, the recalled masks have magnets that connect mask components to hold the BiPAP or CPAP devices 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 has such devices,” according to the FDA.
Medical devices that could be impacted by the magnets include:
- Brain stents;
- Aneurysm clips;
- Pacemakers;
- Implantable cardioverter defibrillators;
- Ventriculoperitoneal shunts;
- Occular implants;
- Magnetic denture attachments;
- Insulin pumps;
- Certain neurostimulators used in and around the neck;
- Cochlear implants
- Any metallic implanted medical device affected by magnets.
“The magnets could also affect mask users who have metallic objects in their body, such as shrapnel or splinters in their eyes, including people near the patient wearing the affected mask, such as a bed partner,” FDA officials noted.
Five mask types are affected by the recall:
- DreamWisp;
- DreamWear;
- Amara View;
- Wisp;
- 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.
A list of recommendations for patients, caregivers, and health care providers regarding the use of masks with magnets from the FDA can be found here.
“This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said.
“We strongly encourage providers and at-risk patients to review this important safety information and follow our recommended actions to reduce the potential for harm from these products.”
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