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BiPAP, CPAP Mask Recall: What You Need to Know

by | Sep 20, 2022

On September 6, 2022, the FDA announced that Philips Respironics had issued a recall for five specific types of masks for BiPAP (Bilevel Positive Airway Pressure) and CPAP (Continuous Positive Airway Pressure) machines.

These machines are used by individuals for the treatment of sleep apnea. In hospitals, they are also used to treat various other breathing problems. The five types of masks affected by the recall are all produced by the same manufacturer, Philips Respironics. The recalled models are:

  • Amara View Full Face Mask
  • DreamWisp Nasal Mask
  • DreamWear Full Face Mask
  • Wisp and Wisp Youth Nasal Mask
  • Therapy Mask 3100 NC/SP
images of five BiPAP and CPAP mask types recalled by Philips
The five mask types recalled by Philips. Image source: FDA

This recall, which is affecting more than 17 million masks, was enacted after Philips Respironics reported 14 cases of serious injuries caused by the interaction with the magnets used in these types of masks. The magnets are used to hold the masks in place in these models. It was found that they interfered with the workings of certain kinds of medical implants and metallic substances within the bodies.

The interaction between the magnets in these masks and the metal implants is a cause of great concern not only for the user of the mask, but also anyone nearby while the mask is in use. For example, if a married couple sleeps together, one partner’s mask could cause problems with the other partner’s pacemaker.

Potential Health Risks

There are many kinds of metallic objects that might be found in the human body. Some of the most common, or some of the most likely to be adversely impacted by the magnetism of the recalled masks, are:

  • Any device labeled as Magnetic Resonance (MR) Unsafe
  • Pacemakers 
  • Heart defibrillator implants
  • Neurostimulators
  • Magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head
  • Metallic stents
  • Aneurysm clips
  • Gastrointestinal clips
  • Implantable ports and pumps (such as insulin pumps)
  • Cranial plates
  • Some bone and joint replacement devices
  • Ocular implants
  • Implants in the inner ear such as cochlear implants, implanted bone conduction hearing devices, and auditory brain stem implants

The interaction between the magnets in the recalled masks and some metallic substances in the body could have potentially fatal consequences. Magnetic interference with pacemakers and other devices designed to regulate the heartbeat could mean a heart attack or life-threatening heart failure.

The magnets could cause metallic substances in the body to shift, creating tissue damage. They could cause shunts to shift, leading to a buildup of pressure in the brain or eyes. The list goes on and on, though fortunately, the recall was issued before any of these worst-case scenarios came to fruition.

Of the 14 incidents reported to Philips Respironics, luckily, none of them resulted in the death of the user. However, they did result in a pacemaker failure, a shifted shunt which required surgical re-adjustment, and the unintentional resetting of an automatic implanted cardioverter defibrillator. Among the other reported symptoms were changes in heart rate, headaches, seizures, and arrhythmia. It’s highly likely that these incidents were underreported as well.

Alternatives to BiPAP and CPAP

If you are currently using one of the recalled models of mask and you or anyone who may be near you has any metallic substances in their bodies, it is strongly advised that you consult with your healthcare provider immediately to see if your treatment plan needs to change.

If you are interested in finding ways to treat your sleep apnea without BiPAP or CPAP, there are alternatives available. Oral appliance devices by professional sleep specialists such as SleepWell Louisiana have helped many clients. Looking for BiPAP or CPAP alternatives in Lafayette, LA? Contact us today to take an at-home sleep test to see how our oral devices can help you get a sounder, safer night’s sleep.