Philips Trilogy Evo Ventilator Recall Issued After Serious Injuries Reported

The FDA’s recall designation is the latest in a string of problems linked to Philips ventilators, CPAP machines and other breathing assistance devices.

Federal health regulators have determined that a correction notice sent out by Philips involving problems with its Trilogy Evo ventilators should be considered the most serious classification of recall, following reports of multiple injuries.

The U.S. Food and Drug Administration (FDA) announced the Philips Respironics Trilogy Evo Platform ventilator corrective action recall on April 15, although the manufacturer is not currently planning to pull the affected units from the market..

Philips Trilogy Evo Platform ventilators are used to assist patients who need mechanical ventilation to breathe, providing both continuous positive airway pressure (CPAP) and intermittent positive airway pressure breathing support. The devices are for pediatric and adult patients and are used in hospitals, homes, or non-emergency transport settings.

Trilogy Evo Ventilator Problems

Philips issued the corrective action because of three issues affecting the devices, including problems with the non-pneumatic nebulizers, flow sensors, and obstruction alarms.

The first problem occurs when non-pneumatic nebulizers are used with Trilogy ventilators. A discrepancy between the set tidal volume and the tidal volume received by the patient can cause a change in the ventilator’s leak estimation calculation, leading to under-delivery of ventilation therapy.

The second issue occurs when aerosol enters the ventilator and accumulates on the internal flow sensor. Buildup can interfere with accurate airflow measurement, leading to incorrect flow calculations, impacting therapy.

The third issues occurs when the Obstruction Alarm does not trigger when it is supposed to, which is at two breath cycles or five seconds. In some modes, with or without backup rates, the alarm could be delayed by up to four breaths.

As a result of these problems patients can suffer from hypoventilation, inflation of the lungs, low oxygen saturation, inadequate or inappropriate treatment, shortness of breath, over- or under-delivery of tidal volume, under-delivery of FiO2, and in some cases, the ventilator will stop functioning all together. At least three serious injuries have been associated with the ventilator problems.

The FDA has classified the Trilogy Evo ventilator correction notice as a class I recall, the most serious classification, because the device may cause serious injury or death if patients continue to use it without correction.

The recall impacts the following Trilogy ventilators:

• Trilogy Evo – DS2110X11B
• Trilogy EV300 – DS2200X11B
• Trilogy Evo O2 – DS2100X11B
• Trilogy Evo Universal – DS2000X11B

The corrective action urged consumers to stop using the non-pneumatic nebulizers, including vibrating mesh nebulizers, with all Trilogy Evo Platform ventilators. Users and healthcare professionals should also update the software version 1.05.15.00. The software is available as a free download through the My Philips for Professionals (MyP4P) and InCenter websites.

Philips also called for owners of the devices to notify anyone in their organization or facility who interact with the ventilators to be aware of the correction notice.

Homecare Customers with questions can contact Philips at 1-800-345-6443, while hospitals should call 1-800-722-9377

Philips Breathing Device Problems

This is not the first time Philips ventilators or other breathing assistance devices have undergone mechanical issues leading to patient health risks and device recalls.

In August 2023, Philips issues a recall for Trilogy Evo Ventilators, citing problems with debris in the breathing tubes, leading to life-threatening injuries. The recall affected 70,000 Trilogy Ventilators and it was classified as a Class I recall.

Several months later, in March 2024, Philips issued a correction notice for Trilogy EVO ventilators, warning the devices could lead to loss of breathing support for patients. However, by May 2024, another recall for the Trilogy EVO ventilators was issued due to software defects that could lead to death.

In November 2024, Philips issued updated instructions for Trilogy ventilators to address aerosol deposit risks, but the FDA still classified the action as a Class I recall, warning the issue could cause serious injury or death.

In 2021 Philips issued a massive recall affecting millions of CPAP, BiPAP and ventilators due to problems with toxic sound abatement foam used inside the devices. According to the FDA, the problem was linked to more than 350 patient deaths, thousands of injuries and led to a massive number of Philips CPAP recall lawsuits that resulted in a $1.1 billion settlement to resolve individual claims, and nearly $500 million to resolve class action claims.

Inspire Sleep Apnea Device Problems

In recent months, attention has been focused on problems with the Inspire Upper Airway System (UAS) by Inspire Medical Systems, Inc.

The Inspire Upper Airway System (UAS) was first approved by the U.S. Food and Drug Administration in 2014. It consists of a small implantable pulse generator in the chest, a stimulation lead that activates the hypoglossal nerve to move the tongue forward, and a sensing lead that tracks breathing patterns.

In 2024 the company announced an  Inspire IV IPG recall due to reports of patients suffering electric shocks. The devices have also been linked to increased risk of infections, nerve damage, pain or device migration, which can lead to excessive electrical stimulation and muscle spasms.

This has led to a growing number of individual Inspire sleep apnea device lawsuits, as well as investor lawsuits claiming the company deceived shareholders about the development and rollout of the devices. As a result, product liability lawyers are investigating claims for individuals who experienced complications or required surgery to remove the device.