Philips C-PAP and Other Ventilator Machines Recalled Due To Toxic Foam

A Philips CPAP machine recall impacts nearly 4 million sleep apnea and breathing devices with toxic sound abatement foam.

Philips Respironics has issued a massive CPAP machine recall impacting millions of sleep-apnea devices and mechanical ventilators, which contain sound abatement foam that may degrade over time and release toxic gasses, potentially exposing users to a risk of cancer.

The Philips Bi-PAP, C-PAP and ventilator recall was announced by the manufacturer on June 14, after identifying a potential health risk associated with the device’s polyester-based polyurethane (PE-PUR) sound abatement foam, which the company warns can degrade and release particulate matter into patients’ airways.

Approximately 3.5 million Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices were equipped with PE-PUR sound abatement foam, which are being withdrawn from the market due to evolving health concerns.

Philips announced this week that internal testing revealed the PE-PUR sound abatement foam has the potential to “degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.” Philips indicated the particulate matter and gases may be toxic to patients and could potentially cause cancer.

To date, Philips has received several complaints suggesting that users are experiencing potentially serious side effects from using the CPAP machines including headaches, irritation, inflammation and respiratory issues after inhaling the polyester-based polyurethane foam.

The manufacturer has suggested that the use of unapproved cleaning methods like SoClean may cause the CPAP foam problems. Exposure to high heat and high humid environments may also be a contributing factor that accelerates deterioration of the PE-PUR sound abatement foam. However, an investigation is still ongoing.

Owners of the recalled Philips C-PAP and Bi-Level PAP machines, representing about 80% of the impacted devices, have been instructed to stop using the devices immediately, and to consult with their healthcare professional for an alternative.

The remaining 20% of the recalled devices are mechanical ventilators. Philips recommended doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks.

The recall notice claims the company is working closely with regulatory agencies to provide customers a resolution which will include the deployment of updated instructions for use and a comprehensive CPAP machine repair and foam removal program for the recalled devices.