More than 70,000 Philips Trilogy Evo ventilators are being recalled due to the risk of debris becoming lodged in the machines’ breathing tubes.

These same ventilators were recalled in March 2023, but this latest recall has been given Class 1 designation by the U.S. Food and Drug Administration after at least one death, two injuries and 542 complaints were linked to the Philips Respironics devices

Dust and dirt from the environment can become trapped in the air path of the ventilators. A buildup of debris over time can block air vents, which may cause a decrease in the amount of air pressure delivered. This could lead to patients not getting enough oxygen or a buildup of carbon dioxide, both of which have the potential for death or serious injury.

The recall covers these Philips ventilators:

  • Trilogy Evo
  • Trilogy Evo O2
  • Trilogy EV300
  • Trilogy Evo Universal

Devices were distributed between March 26, 2019, and March 22, 2023. Serial numbers affected can be found in the FDA’s recall notification.

Ways to Prevent Complications

There are several actions that can be taken to avoid any potential risks from the devices, according to a product notice distributed by Philips:

  • Use only Philips-approved particulate filters. 
  • Use the air-inlet filter. 
  • Replace the filter between patients.

Users are urged to set appropriate alarms on the devices and to follow instructions should an alarm sound. For example, the “inlet filter blocked” alarm will trigger if air pressure is reduced. The FDA recommends having additional ventilation equipment on hand as back-up in case an issue cannot be resolved. 

Anyone with questions about the devices or the recall should contact their local Philips representative or Philips Respironics customer service at 1-800-345-6443. Hospital customers may call 1-800-722-9377.

Past Recalls and Ongoing Lawsuits

Philips issued a major recall of CPAP and BiPAP machines and ventilators due to health risks in June 2021. The polyester-based polyurethane sound abatement foam in the devices had the potential to break down. The foam can then become inhaled or swallowed by users. This recall was followed by an FDA Class 1 recall for certain Philips CPAP and BiPAP DreamStation respiratory devices in 2023.

By the end of 2022, the FDA had received more than 98,000 reports of side effects connected to foam in the machines breaking down. There were 346 deaths linked to the issue, along with several reports of other serious health issues.

Thousands of Philips CPAP lawsuits were filed by people using the recalled devices to treat sleep apnea. The lawsuits claim Philips made defective machines that put people at risk. As of July, there were 673 cases still pending in multidistrict litigation. Bellwether test trials may begin as soon as 2024.