Philips CPAP Recall

People who rely on Philips Respironics CPAP and BiPAP machines or ventilators for breathing assistance may be at risk for cancer and other serious or potentially life-threatening side effects due to allegedly defective sound abatement foam used in the devices, which could release black debris or certain chemicals into the devices’ airpath circuit. If you or someone you love has suffered carcinogenic effects or other serious injuries after using a now-recalled Philips Respironics ventilator, CPAP or BiPAP machine, contact us right away to discuss the possibility of filing a product liability lawsuit against the manufacturer.

CPAP Cancer Recall Lawsuit

Philips CPAP Recall Lawsuit Information

Philips Respironics recently issued an urgent medical device recall affecting certain ventilators and CPAP and BiPAP machines manufactured between 2009 and April 26, 2021, due to issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration in the affected devices. According to the FDA, the sound abatement foam may break down into particles (black debris), which could then enter the device’s air pathway and be swallowed or inhaled by the user. As it degrades over time, the foam could also release certain chemicals into the device’s air pathway, which could put users at risk for adverse health effects if inhaled.

“These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage,” the FDA warns. In the wake of the Philips CPAP recall, a growing number of lawsuits are expected to be brought against Philips Respironics by former users of the recalled CPAP, BiPAP and ventilator devices, for injuries allegedly occurring as a result of swallowing or inhaling harmful foam debris or chemicals off-gassed from the defective sound abatement foam.

Possible Injuries Linked to the Philips CPAP Recall

The potential risks of swallowing or inhaling black debris from the PE-PUR sound abatement foam include:

• Skin, eye, or respiratory tract irritation
• Inflammatory response
• Asthma
• Headache
• Adverse effects to kidneys, liver, and other organs
• Carcinogenic effects

The potential risks of chemical exposure due to off-gassing from the foam include:

• Headache
• Dizziness
• Eyes, nose, skin, or respiratory tract irritation
• Hypersensitivity
• Nausea
• Vomiting
• Toxic and carcinogenic effects

Cancers we are investigating include:

• Bladder Cancer
• Brain Cancer
• Breast Cancer
• Hematopoietic (Blood) Cancer
• Kidney Cancer
• Leukemia
• Liver Cancer
• Lung Cancer
• Lymphatic Cancer
• Multiple Myeloma
• Nasal Cancer
• Non-Hodgkin Lymphoma
• Papillary Carcinoma
• Prostate Cancer
• Rectal Cancer
• Stomach Cancer
• Testicular Cancer
• Thyroid Cancer

According to the FDA, “the sound abatement foam may break down into particles (black debris), which could then enter the device’s air pathway and be swallowed or inhaled by the user. As it degrades over time, the foam could also release certain chemicals into the device’s air pathway, which could put users at risk for adverse health effects if inhaled.” “These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage,”

What Do the Recalled Devices Do?

The medical devices affected by the Philips Respironics recall are all designed to provide users with some form of breathing assistance. More specifically, the recalled continuous positive airway pressure (CPAP) machines are meant to keep the user’s airway open by providing a continuous stream of air through a mask. These devices are commonly prescribed to people with obstructive sleep apnea, a sleep disorder in which a person involuntarily stops breathing for short periods of time while sleeping. Bilevel positive airway pressure (BiPAP) machines help open the lungs by supplying pressurized air into the user’s airways. And continuous ventilator devices are used to mechanically control or assist users’ breathing by delivering breathing gas containing a predetermined percentage of oxygen.

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+

Noncontinuous Ventilator

  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go
  • Dorma 400
  • Dorma 500
  • REMstar SE Auto

Continuous Ventilator

  • Trilogy 100
  • Trilogy 200
  • 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

History of the Philips CPAP Recall

The first indication of a potential problem with Philips Respironics CPAP and BiPAP devices and mechanical ventilators came in April 2021, when the company announced that it was conducting an ongoing analysis of possible health risks related to the sound abatement foam used in specific breathing assistance machines. On June 14, 2021, Philips Respironics recalled the affected CPAP, BiPAP and ventilator devices, due to possible health risks, including exposure to degraded sound abatement foam. The company announced at that time that it had “developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.”

More than two weeks later, on June 30, 2021, the FDA issued a safety communication notifying consumers and healthcare professionals that certain Philips Respironics ventilators, CPAP and BiPAP machines had been recalled due to the potential risk of users ingesting or inhaling toxic particles or chemicals from degraded foam. According to the recall announcement, Philips Respironics has received several reports of black debris or particles from the foam present within the airpath circuit, as well as reports of injuries ranging from headaches and coughs to upper airway irritation, chest pressure, and sinus infection. The FDA warns that the degradation of the PE-PUR sound abatement foam “may be exacerbated by high heat and high humidity environments, and by use of unapproved cleaning methods, such as ozone.”

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