FDA Recalls Philips BiPAP and CPAP Machine Masks

On September 6, 2022, the FDA shared that Philips recalled specific Philips Respironics masks for BiPAP and CPAP machines. The FDA’s news release shares that these devices have magnets in them, which can interfere with other medical devices such as pacemakers, metallic stints, and aneurysm clips.

According to the FDA news release, the dangers of using these recalled devices are not just limited to the patient using them.

The FDA states, “these potential adverse events can occur in people who use the masks, or in people near a person using the mask. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.”

The devices recalled are the Amare View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, and Therapy Mask 3100 NC/SP.

The press release also emphasizes that, in the medical device report submitted by Philips on August 30, 2022, 14 serious injuries were reported, including pacemaker failure. Pacemaker failures have led to necessary replacements, headaches, cognitive changes, and more.

In the recommendations by the FDA, the organization urges healthcare providers to share this recall information with their patients and provide information on additional mask options without magnets if they or someone close to them have metallic devices.

A minimum of six inches between the recalled device and metallic medical implants, metallic objects in the body, or medical devices impacted by magnetic fields is advised.

Moving forward, healthcare professionals should dispose of recalled masks they have on hand, address concerns, and share information with patients regarding the recalled devices. Additionally, they should not prescribe the mask to anyone with a device that can be impacted.

Providers who prescribe this device should also plan to ask about medical devices used by anyone around the patient.

“The FDA is also evaluating the safety of magnets that may be present in masks or similar interfaces from other manufacturers that are used in sleep medicine and that may have the potential to impact patient safety. The FDA intends to alert these manufacturers if appropriate and take necessary steps to address any issues that may be identified,” stated the press release.

As further research is conducted, users and prescribers of BiPAP and CPAP machines should monitor the advisory information for the devices and adjust their actions accordingly.