BIRMINGHAM, Alabama (January 27, 2022)—The Food and Drug Administration has expanded Philips Respironics’ product recall, adding the Trilogy Evo ventilator and muffler repair kits to the list—and declared it a level 1 recall, the most severe.
At issue is same polyester-based polyurethane (PE-PUR) foam used for sound abatement in a range of devices, included Cpap and Bi-PAP devices that were recalled by Philips in June 2021. A Philips supplier incorrectly used the foam in the muffler assembly of the affected Evo ventilators, which are sold in the United States and Korea.
The foam “may break down and potentially enter the device's air pathway. If this occurs, black debris from the foam or certain chemicals released into the device's air pathway may be inhaled or swallowed by the person using the device,” states the FDA’s recall notice, posted January 26, 2022. The issue was discovered during lab testing and there have been no injuries or deaths reported, the FDA said.
Evo models with these serial numbers are included in the recall. The recall affects approximately 500 individual Trilogy Evo ventilators manufactured between April 15, 2021 and May 24, 2021, and approximately 230 Trilogy Evo muffler assembly repair kits.
Trilogy 100 and 200 ventilators were included in the June 2021 recall due to the same risk. The Trilogy Evo 02, Trilogy EV300 and Trilogy Evo Universal are not included in the recall.
The Evo is marketed as a hospital-to-home ventilator designed to facilitate patient transitions between clinical and non-clincal settings and to be portable, such as in a vehicle or wheelchair. It may be used for invasive and non-invasive ventilation.
The FDA says Evo customers were sent a recall notice by Philips on December 21 and the company sent an updated version to clarify information on cleaning and filters January 13. The notice says not to stop or change patient therapy unless a patient has consulted their health care provider or received a replacement Trilogy Evo.
It also says to tell patients and/or caregivers to closely monitor the device’s filter for foam debris.
“Using an inline bacterial filter may help to filter out particles of foam,” the FDA’s notice says. “Additionally, after placement of an inline filter, instruct patients and/or caregivers to be aware of potential changes in breathing circuit resistance and monitor as ventilator performance may change due to increase in resistance of air flow through the device after filter placement. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.”