FDA Singles Out Some Recalled Philips BiPAP and Ventilator Machines Due To Risk To Patients

Following a massive recall issued last month for more than 3.5 million Philips DreamStations and other breathing machines that contain PE-PUR sound abatement foam, which may degrade and release toxic particles directly into the air pathways, federal health officials are highlighting the particularly serious nature of the risk which may be associated with more than 200,000 of the devices, including certain mechanical ventilators and BiPAP machines.

The Philips PE-PUR foam issues resulted in a recall of nearly two dozen different models of CPAP, BiPAP and ventilators on June 14, most of which were non-life sustaining sleep apnea machines.

As a result of the health risks associated with inhaling the foam particles or gases released as the foam breaks down, individuals using the CPAP and BiPAP machines for sleep apnea were urged to immediately stop using the devices. However, officials indicated that individuals relying on recalled ventilators for life-sustaining therapy should not stop using the product until they speak with their healthcare providers, and continued use of certain machines may be necessary.

In a recall notice posted on July 22, the FDA indicates the action taken with regard to 204,776 of the ventilators and BiPap machines distributed between November 5, 2005 and April 23, 2021 is considered a Class I recall, which is the most serious type of recall that can be issued, and suggests that the products may cause serious injury or death.

The Class I designation includes the Trilogy 100, Trilogy 2oo, Garbin Plus, Aeris, LifeVent 200, BiPAP V30, and BiPAP A30/Hybrid/A40 devices, which are used to used to provide mechanically controlled breathing or bilevel positive airway pressure assistance.

Since alternate ventilator options may not exist or be in limited supply, officials indicate doctors may determine that continued usage of these devices may outweigh the risks. In those cases, physicians are urged to use an inline bacterial filter to attempt to catch the foam debris and prevent it from entering the airway, but that has not been established as safe and effective, and may increase resistance of air flow through the device.

The FDA indicates the filters will not help reduce exposure to certain chemicals which may be released by the PE-PUR foam, and the devices should be closely monitored for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.

Most of the other recalled Philips breathing machines are DreamStations or similar products used in private homes for sleep apnea. Even though replacement CPAP machines may also not be available or in limited supply, those users have been urged to immediately stop using the devices and speak with their doctors about other strategies for managing risks associated with sleep apnea.

In the wake of the recall, thousands of Philips CPAP machine lawsuits are expected to be filed by individuals who have experienced symptoms or injuries following exposure to the PE-PUR foam, including headaches, dizziness, cough, chest pressure, nausea, vomiting and eye, skin, nose or respiratory tract irritation. In some cases, plaintiffs allege that they have been diagnosed with serious and potentially life-threatening injuries like cancer, kidney disease, liver disease, myocardial infarction, heart failure, stroke, respiratory failure, hypersensitivity or asthma.