Philips Trilogy Evo ventilators have been recalled more than once. The problems include foam breakdown, software faults and nebulizer use. The FDA classified the December 2021 foam recall as Class I. A March 2026 notice added a nebulizer warning.
No MDL has been formed for Trilogy Evo ventilators. Regulators and Philips describe risks of sudden loss of ventilation and under-delivery of therapy. Health Canada added a 2024 recall for a battery software issue.
Philips told users not to use non-pneumatic nebulizers with these devices and to update the software. Owners should check whether their device’s model and serial number fall under a recall.
- Case or litigation name: No Trilogy Evo MDL
- Defendants: None named in an MDL
- Court and docket number, when available: No MDL docket
- MDL number, judge, and case count, when an MDL exists: No MDL
- Filing date: No MDL transfer order
- Main allegations: Regulators describe foam breakdown, loss of ventilation and under-delivery of therapy
- Products or people involved: Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 ventilators
Table Of Contents
Latest Trilogy Evo Ventilator Lawsuit Updates
April 8, 2026: Nebulizer Warning and Class I Recall
Philips sent an urgent field safety notice in March 2026. It told customers to stop using non-pneumatic nebulizers with Trilogy Evo ventilators. This includes vibrating mesh nebulizers.
The action was posted as a Class I recall. It covers more than 113,700 devices worldwide. A Philips spokesperson said the ventilators may be used safely by following the revised instructions.
April 9, 2024: Court Enters Consent Decree
The FDA reported that a federal district court entered a consent decree against Philips Respironics. The decree requires a Recall Remediation Plan [1].
It also limits production and sale of new CPAP, BiPAP and other devices at several Philips Respironics facilities. The limits last until requirements are met. The decree concerns the separate June 2021 recall of CPAP, BiPAP and ventilator devices.
March 4, 2024: Battery Software Recall Starts in Canada
Health Canada listed a recall start for Trilogy EVO and EV300 ventilators over a battery software issue. The Health Canada notice says the issue can trigger a loss of power alarm while sufficient power is still available [2].
Health Canada classed it as a Type II recall under number RA-75281. Its notice lists catalog number CA2110X12B for the Trilogy EVO and CA2200X12B for the Trilogy EV300.
January 26, 2022: FDA Classifies Evo Recall as Class I
Respiratory Therapy reported the FDA’s Class I rating of the December 2021 Evo recall in January 2022 [3]. It covers units distributed April 15 to May 24, 2021. Philips began it after incorrect polyester polyurethane foam was used.
June 30, 2021: FDA Issues Safety Communication
The FDA published a safety communication on the Philips recall of ventilators, BiPAP and CPAP machines. The recall was due to PE-PUR foam breakdown risks. It lists Trilogy 100 and 200 ventilators among the devices.
The FDA says black pieces of foam, or chemicals that are not visible, could be breathed in or swallowed by the person using the device.
What Is a Trilogy Evo Ventilator?
According to MedTech Dive, Philips’ Trilogy Evo ventilators provide invasive and noninvasive ventilation. They can be used at home or during patient transport [4].
Philips Respironics makes the line. Each recall has its own notice and scope, so a device may fall under one recall and not another.
Who May Be Affected?
Owners of Trilogy Evo ventilators in the December 2021 foam recall may be affected. That recall is by serial number. The FDA directs users to Philips for the serial list.
Users of Trilogy EVO and EV300 devices in the 2024 software recall may also be affected. Health Canada lists catalog numbers for that recall.
The 2026 notice covers Trilogy Evo, Evo O2, Evo Universal and EV300 ventilators. The Judicial Panel on Multidistrict Litigation has not formed an MDL for them. Each case needs an individual legal review.
Reported Injuries or Damages
These statements come from regulators and Philips, not from complaints or medical findings. The FDA says problems reportedly linked to PE-PUR foam breakdown could potentially result in serious injury. The problems may require medical care to prevent permanent injury.
Philips says the 2024 software issue can cause a sudden loss of ventilation while the device alarms. The 2026 notice warns of under-delivery of therapy.
The FDA foam testing summary says the agency did not believe Philips’ testing was adequate to fully evaluate the risks [5]. That statement dates from October 2023.
Recall and Regulatory Background
Three recalls cover Trilogy Evo ventilators: the December 2021 foam recall, the March 2024 software recall and the March 2026 nebulizer recall. A recall does not by itself establish liability or eligibility for a claim.
Related litigation is covered on the Philips CPAP recall lawsuit page. That page covers the larger Philips recall of CPAP and BiPAP machines.
Evidence to Preserve
If you used a Trilogy Evo ventilator, keep these items together in one safe place:
- Device model and serial number
- Purchase or rental records and the supplier
- Photographs of the device and any visible foam particles
- Medical records, prescriptions and hospital or home-care notes
- Copies of recall or field safety notices received
- Communications with Philips, the supplier or the provider
- Records of nebulizer or software settings in use
Keep both paper and digital copies of each item. Do not change or delete any of these records, even if they seem minor or unrelated.
Filing Deadlines
Filing deadlines for injury claims come from state law, so the rules depend on where you live and which state’s courts would hear your case.
The deadlines also depend on when the injury happened and when its link to the device was discovered, which can differ for each person.
Missing a deadline can end a claim even when the facts are strong, so talk to a lawyer promptly to protect your options.
Frequently Asked Questions
Did Philips Stop Making Trilogy Evo Ventilators?
MedTech Dive reported that Philips discontinued the Trilogy Evo ventilators in January 2024. The devices continued to be available as they were deemed medically necessary under the consent decree, the report said.
What Does the Research Say About Foam Breakdown?
Research on foam breakdown comes from the FDA’s foam testing summary, current as of August 15, 2024. It says Philips agreed to conduct the additional testing the FDA requested. The FDA maintains its recommendations.
How Do I Report a Problem with My Trilogy Evo Ventilator?
To report a problem with your Trilogy Evo ventilator, send the FDA a MedWatch Voluntary Reporting Form. You can also call 1-888-INFO-FDA (1-888-463-6332) to reach the FDA.
Is the Trilogy Evo Recall Part of the Philips CPAP Recall?
The FDA’s Philips recall page also lists certain Trilogy Evo ventilators with specific serial numbers. They are recalled alongside Philips CPAP and BiPAP machines. The June 2021 recall on that page affected 15 million devices worldwide.
References
- https://www.fda.gov/medical-devices/respiratory-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines
- https://recalls-rappels.canada.ca/en/alert-recall/trilogy-evo-and-ev300
- https://respiratory-therapy.com/products-treatment/industry-regulatory-news/recalls-advisories/fda-update-on-trilogy-evo-recalls/
- https://www.medtechdive.com/news/philips-warns-not-to-use-certain-nebulizers-in-trilogy-evo-ventilator-recal/816981/
- https://www.fda.gov/medical-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines/foam-testing-summary-recalled-philips-ventilators-bipap-machines-and-cpap-machines