FDA: Recalled Philips BiPAP, CPAP machines tied to more than 560 deaths

The U.S. Food and Drug Administration has updated a recall affecting millions of Philips sleep apnea machines, now saying that they may been linked to at least 561 deaths.

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The agency, in a statement issued last week, said it has received more than 116,000 reports about the breathing devices — BiPAP and CPAP machines — over nearly three years.

The machines, they say, have been found to break down and cause serious health hazards including choking, inhalation of foreign particles and an increased risk of cancer.

According to the FDA notice, the material used to make the machines, polyester-based polyurethane (PE-PUR) foam, breaks down over time, and the particles from the foam can enter the airway of the person using the device.

As the agency noted in its initial alert, “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.”

Philips issued an initial recall of more than 5 million of the devices in 2021.

Philips has since said they will no longer sell the devices in the U.S.

“Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these medical device reports,” the company said in a statement. “Importantly, the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death.”

Which devices have been recalled?

Devices included in the recall are:

• A-Series BiPAP A30
• A-Series BiPAP A40 (ventilator)
• A-Series BiPAP Hybrid A30
• A-Series BiPAP V30 Auto (ventilator)
• C-Series ASV (ventilator)
• C-Series S/T and AVAPS
• DreamStation
• DreamStation ASV
• DreamStation Go
• DreamStation ST, AVAPS
• Dorma 400
• Dorma 500
• E30
• Garbin Plus, Aeris, LifeVent (ventilator)
• OmniLab Advanced+
• REMstar SE Auto
• SystemOne ASV4
• SystemOne (Q-Series)
• Trilogy 100 (ventilator)
• Trilogy 200 (ventilator)
• Certain Trilogy Evo ventilators with specific serial numbers.

According to the FDA, some products that were modified to resolve the issue have been recalled as well.

Those products include:

• Trilogy Evo ventilator model numbers with certain serial numbers as listed in the recall database:
• DS2110X11B
• KR2110X15B (not distributed in the U.S.)
• Repair kits for Trilogy Evo muffler assembly model and lot numbers as listed in the recall database:
• Part number 1135257
• Lot numbers between 210414 and 210524

Philips has agreed to pay at least $445 million in compensation to users of the devices under a proposed class-action settlement for people who purchased a recalled Philips Respironics CPAP, BiPAP, or Ventilator sold in the U.S. between 2008 and 2021.

People who believe they may be entitled to part of this settlement can check their eligibility here.

Sleep apnea is a condition where breathing stops and restarts during sleep.

According to a National Institute of Health study, an estimated 1 billion people are affected globally by sleep apnea.

A person with sleep apnea wakes up numerous times during the night — in some cases as many as 100 times in an hour — as their breathing stops. A common symptom of sleep apnea is loud snoring, according to the Cleveland Clinic.

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