01/26/2022 – FDA Issues additional recall on Phillips Trilogy EVO ventilators.
11/12/21 – FDA Issues CPAP recall update: https://www.fda.gov/news-events/press-announcements/fda-provides-update-recall-certain-philips-respironics-breathing-assistance-machines
Today (7/23/21), the U.S. Food and Drug Administration (FDA) changed the designation of the Phillips CPAP recall to Class 1, its most serious level.
The number of CPAP lawsuits our lawyers are being contacted about has increased with more news on this topic. The number of affected individuals is thought to be in the millions.
After careful analysis of the FDA Adverse Event Reporting System, our lawyers have discovered that there have been more than 1,200 complaints to the FDA and more than 100 injuries reported involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down.
If you or a loved one has suffered side effects or complications associated with the recalled Phillips CPAP machines, you may want to speak with the lawyers at Johnson // Becker.
Why Did Phillips Issue The CPAP Recall?
On June 20, 2021, the FDA issued an urgent safety communication recall of certain Philips Respironics BiPAP, CPAP, and ventilator machines due to potential health hazards.
The PE-PUR (polyester-based polyurethane) sound abatement foam used in these machines may break down and enter into the device’s air pathway. Should this happen, certain chemicals or black debris from the foam could be inhaled or swallowed by the person using the device.
The recall was issued because PE-PUR foam used in these devices can be inhaled or swallowed, which may be life-threatening, cause serious impairment, or immediate medical intervention to prevent further damage.
Complaints of Foam Particles Causing Breathing Problems
Philips Respironics has been alerted to this issue through several complaints of black debris/particles in the device air pathway. Many reports included headache, upper airway irritation, cough, chest pressure, and sinus infection.
Exposure to particles such as black debris includes skin and eye irritation, respiratory tract infection, asthma, headaches, toxic or carcinogenic effects to the organs such as kidneys and liver.
Chemical exposure can include the aforementioned side effects as well as nausea and vomiting, and skin hypersensitivity.
The current theory is that foam degradation may be caused by high heat and humid environments, as well as unapproved cleaning methods. There are currently no deaths associated with these issues, but the potential is there.
The recall includes Phillips devices that were manufactured between 2009 and April 26, 2021:
Continuous Ventilator, Non-life Supporting
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
- Trilogy 100
- Trilogy 200
- 215 Trilogy Evo ventilators;
- 51 Trilogy Evo repair kits
- Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting
- A-Series BiPAP A40
- A-Series BiPAP A30
According to the American Sleep Association, nearly 22 million Americans suffer from sleep apnea. For those that receive help, the first thing they may need for treatment is a CPAP or BiPAP machine.
- CPAP stands for continuous positive airway pressure machine and keeps the airways open with a steady stream of air through a mask. When you are diagnosed with obstructive sleep apnea, this device is typically recommended.
- BiPAP stands for bilevel positive airway pressure. Under pressure, it pumps air into the airway of the lungs. They have a higher amount of pressure as the patient breathes in and lower pressure when they breathe out.
- Ventilators are a mechanically controlled device that assists a patient in breathing. It provides a predetermined percentage of oxygen in the breathing gas.
The FDA is reviewing medical device reports (MDRs) related to the devices over the years 2009-2021. Additionally, no other CPAP, BiPAP, and ventilators from Philips or other manufacturers are affected by this recall.
Do I have a CPAP Recall Lawsuit? Contact our Lawyers for a Free Case Review.
If you or a loved one has suffered side effects from a recalled CPAP machine, you may want to speak with the lawyers at Johnson // Becker. We are actively investigating new CPAP complication lawsuits across the county and you may be entitled to financial compensation for your injuries.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386. We would be honored to speak with you and respond promptly to every inquiry we receive.