The CPAP Machine Recall: What You Need To Know

In June 2021, Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines due to potential health risks. The recall was classified as Class I – the most serious type of recall. 

Since its announcement, the recall has impacted approximately 2 million people in the United States. Below, we dive into more detail about the associated health risks and what you can do about the recall as a practicing physician and/or as an Obstructive Sleep Apnea (OSA) patient.

cpap machine recall

Why CPAP Machines Have Been Recalled

The polyester-based polyurethane (PE-PUR) foam used in many of the Philips ventilators, bi-level positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines utilized to lessen sound and vibration were found to be able to break down. 

If this foam breaks down, black pieces of foam or certain chemicals that are invisible to the naked eye could be breathed in or swallowed by the person using the device. Breathing in chemicals or swallowing small pieces of broken-apart foam has the potential to result in serious injury, cause permanent impairment, and/or require medical intervention to prevent permanent injury.

The FDA classified the June 2021 recall as Class I, which involves a reasonable probability that “…the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”1

Snoring and sleep apnea can be caused by the airway at the back of your throat narrowing while you sleep. Oral appliances, like our SomnoMed Avant, move your jaw and tongue forward while you sleep to open up your airway and treat your sleep apnea.

SomnoMed is the world’s largest supplier of oral sleep apnea devices, operating in 28 countries. Since 2004, we’ve helped more than 760,000 patients have a comfortable night’s sleep while effectively treating their sleep apnea. We’ll make your device to the same medical device quality standards that are used for pacemakers to make sure your device is comfortable for your first night – and every night’s – sleep.

 

What CPAP Machines Are On Recall

Philips Respironics issued a voluntary recall of millions of CPAP machines and bilevel-positive airway pressure (BiPAP) devices in June 2021. The reason for the recall was due to Philips and the FDA stating the machines were defective, and that pieces of foam inside the devices were liable to break down, potentially causing users to inhale black foam particles. 

It’s therefore essential for anyone with a recalled Philips device to immediately consult with their doctor about alternative treatment options. As major product recalls like these tend to raise questions and concerns, getting accurate information about Philips and its recalled products is critical. 

Current list of Recalled Devices

According to the FDA, every CPAP, BiPAP and ventilator device manufactured prior to April 2021 are subject to recall. Affected models include the following: 

  • DreamStation
  • DreamStation Go
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • A-Series BiPAP A30
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP A40
  • A-Series BiPAP V30 Auto
  • C-Series S/T and AVAPS
  • Dorma 400
  • Dorma 500
  • E30
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne Q-Series
  • Garbin Plus, Aeris, LifeVent
  • Trilogy 100
  • Trilogy 200

In addition to the models listed above, some Trilogy Evo ventilators are also part of the recall. 

Are ResMed Devices Part of the Recall?

The Philips CPAP recall caused other CPAP users to question the safety of their devices. ResMed devices, however, are currently stated to be safe to use as directed and are not part of the Philips recall. Since ResMed manufactures their devices using a different material than what Philips used in their recalled machines, all ResMed users are free to continue using their devices as prescribed. 

 

What Do You Do If Your CPAP Machine Has Been Recalled?

Stopping the use of a CPAP device can, in some cases, be riskier than continuing its use. Patients should speak with their medical or dental providers about whether the benefits of using the device outweigh the risks – especially if a patient’s Obstructive Sleep Apnea (OSA) is severe.

Unfortunately, at the time of this writing, Philips has not yet provided the FDA with all information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices. If patients have a health issue and are currently using or have used a recalled or replaced device – or have any problem with their device – it’s recommended by the FDA for patients to speak with their health care provider about it and report the problem through the MedWatch Voluntary Reporting Form.

 

What Is An Alternative To A CPAP Device?

If a patient has been diagnosed with mild or moderate Obstructive Sleep Apnea (OSA), SomnoDent® therapy may be just as effective as CPAP. A SomnoMed sleep apnea oral appliance is an FDA-cleared, custom-fitted dental device specially designed to be an effective, comfortable, and durable alternative to CPAP therapy. Plus, it’s insurance and Medicare approved! The oral appliance works by moving the lower jaw forward, clearing the airway and giving patients a safe and soundless sleep.

How Is SomnoMed® Helping Physicians, Dentists, and Patients During the Recall?

At SomnoMed®, we understand that in many markets, patients receive CPAP as first-line therapy for OSA treatment. However, CPAP isn’t an option or a preferred first choice for everyone. Our Medical Initiative looks to address the reasons why oral appliance therapy is not prescribed as first-line treatment – and strives to change that. 

We work equally with dentists and sleep physicians to help them treat their patients and address the ever-increasing burden of OSA by utilizing oral appliance therapy as an effective CPAP alternative. 

If you are a sleep physician and you have more questions, feel free to contact us here: https://somnomed.com/en/physicians/physicians-contact/

Otherwise, if you are a dentist, reach out to us here: https://somnomed.com/en/dentists/dentists-contact/

 

How SomnoMed Oral Appliances Treat Sleep Apnea

Snoring and sleep apnea can be caused by the airway at the back of your throat narrowing while you sleep. Oral appliances, like our SomnoMed Avant, move your jaw and tongue forward while you sleep to open up your airway and treat your sleep apnea.

SomnoMed is the world’s largest supplier of oral sleep apnea devices, operating in 28 countries. Since 2004, we’ve helped more than 760,000 patients have a comfortable night’s sleep while effectively treating their sleep apnea. We’ll make your device to the same medical device quality standards that are used for pacemakers to make sure your device is comfortable for your first night – and every night’s – sleep.

Compare CPAP and oral appliances over a whole night’s sleep here:

https://effectivenessequation.com/

 

Where To Go From Here

The FDA provided an update on the medical device reports (MDRs) received on May 19, 2022. The FDA continues to review and assess MDRs and has pledged to keep the public informed as new information becomes available.

In the meantime, there are so many challenges that come into play when diagnosing and treating Obstructive Sleep Apnea (OSA), from the OSA screening process to therapy. These include but are not limited to access, education, and awareness. That’s why, here at SomnoMed, we’re rolling up our sleeves in pursuit of a common, universal commitment: to bring more patients into more successful OSA treatment, regardless of therapy. 

If you are a patient, let us help you find the nearest clinic for you.