The U.S. Food and Drug Administration reported that it has received more than 98,000 medical device reports related to machines named in Philips CPAP recalls from June 2021 through October 2022. Between April 2021 and Dec. 31, 2022, there have reportedly been 346 deaths related to the medical devices.

The MDRs include adverse effects reportedly from exposure to volatile organic compounds in PE-PUR sound abatement foam in the CPAP machines. Reported side effects were asthma, breathing difficulty, cancer, chest pain, cough, dizziness, headache, infection and pneumonia.  

Philips released a statement contending, “The vast majority (93%) of the approximately 99,000 MDRs filed since April 2021 up to and including December 2022 are alleged technical malfunctions that do not involve serious injury.”

The FDA announced in its safety communication update that the agency’s “in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports.” 

Philips CPAP Recall Status

Following the initial recall of Philips CPAP, BIPAP and ventilator machines in June 2021, predominantly from the DreamStation line of products, an additional recall was issued in October 2022. The October recall was related to magnetic masks that could negatively impact metal implants in patients, causing injury or death.

Philips reported In December 2022 that the company had conducted studies on most of the devices included in the recalls. The company noted the concerns surrounding its PE-PUR sound abatement foam in the devices were “unlikely to result in an appreciable harm to health in patients.” Philips also asserted that VOCs released from the foam produced “no appreciable harm to health.”

Lawsuits Filed Over Respiratory Issues and Cancers

Patients who used Philips CPAP devices and experienced injury and illness have filed legal claims. Plaintiffs are seeking compensation for medical expenses, lost wages, pain and suffering. 

More than 270 Philips CPAP lawsuits have been consolidated in multidistrict litigation in Pennsylvania as of Feb. 6, 2023, according to the U.S. Judicial Panel on Multidistrict Litigation. There are also claims filed in state courts that aren’t part of the MDL.