CPAP – BiPAP – BiLevel PAP – BPAP recall

In June 2021, the Federal Drug Administration (FDA) required Philips Respironics to recall certain ventilators, BiPap, and CPAP machines. The foam used to reduce sound and vibrations, Polyester-based polyurethane (PE-PUR), was found to disintegrate into micro particles that are then inhaled. These particles can be undetectable while entering the body and can then be transferred into all of the systems of the body causing potentially serious injury to the user. These particles can be undetectable while entering the body and can then be transferred into all of the systems of the body causing potentially serious injury.

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Three main types of devices have been recalled:

Continuous positive airway pressure (CPAP) machines keep your airway open by providing a stream of air at a continuous pressure through a mask. These machines are often prescribed to people with obstructive sleep apnea to keep their airways open during sleep.

Bilevel positive airway pressure (also known as BiPAP, BiLevel PAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. BiPAP machines use a higher pressure when you breathe in and lower pressure when you breathe out.

Continuous ventilator devices mechanically controls or helps patients' breathing while delivering a set amount of oxygen.

Is my device part of the CPAP recall?

Philips Respironics is recalling the following devices made between 2009 and April 26, 2021:

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

The potential risks

Inhaling microparticles or swallowing pieces of foam:

  • Irritation to the skin, eyes, nose, and respiratory tract (airway)

  • Inflammatory response

  • Headache

  • Asthma

  • Toxic or cancer-causing effects to organs, such as kidneys and liver

Inhaling chemicals released into the device’s air tubes from the PE-PUR foam include:

  • Headache

  • Dizziness

  • Irritation in the eyes, nose, respiratory tract (airway), and skin

  • Hypersensitivity reaction, such as an allergic reaction or another immune system reaction

  • Nausea or vomiting

  • Toxic and cancer-causing effects

CPAP recall Case Updates

Recently, hundreds of lawsuits against Philips Respironics have been filed and consolidated into a Multi-District Litigation. The Court has appointed a Steering Committee to move the MDL forward quickly. We have seen many orders already be issued including a decision to allow the parties to enter into a Tolling Agreement which will preserve your claim against Philips Respironics even after the applicable statute of limitations expires.

The FDA also has recently acknowledged that Philips Respironics has not taken satisfactory actions in order to notify customers about the risks associated with their recalled devices. More and more pressure is being put on Philips to act appropriately in the future but, more importantly, make it right with the customers who trusted them with their breathing and their lives.

Why Navigate your Philips CPAP case with a Romano Law Group Attorney

At Romano Law Group, our Mass Tort department is experienced in handling cases nationwide.

We pride ourselves in evaluating each case and treating each client in a Mass Torts case no different than an individual case.

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We Take on Powerful Defendants

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What should you expect?

If you or a loved one were prescribed and used a Philips CPAP, BiPap, or Ventilator between 2009 and 2021 and have experienced or are experiencing headaches, dizziness, irritation of the eyes, nose, throat, hypersensitivity, nausea or vomiting, or have been diagnosed with cancer, you may be entitled to be part of this litigation. If your loved one has died due to these ailments and used a Philips CPAP, BiPap, or Ventilator between 2009 and 2021, you also may be entitled to be part of this litigation. 

At Romano Law Group, our Mass Torts department is experienced in handling cases Mass Torts cases throughout the nation. We pride ourselves in evaluating each case and treating each client in a Mass Torts case no different than an individual case. Be prepared for constant communication, individualized attention, and direct contact with your attorney, not just a staff member. If you have a case that is considered a Mass Tort and want to discuss how we can assist you further, do not hesitate to give us a call. 

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