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Sleep Apnea Machines, Ventilators Recalled Due to Cancer Risk Posed by Foam

July 6, 2021 in

Important Update:

As of July 22, 2021, the FDA has identified the Philips recall as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Overview of Recall

Medical device maker Philips announced a voluntary recall of sleep apnea machines and ventilators due to toxic foam material that may put users at risk of cancer and other health issues. 

 

Philips logo

Medical device maker Philips is issuing a voluntary recall on ventilators and sleep apnea machines due to toxic materials.

 

The recall includes millions of units of the Philips Bi-level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. Most of these recalled devices are DreamStation products. 

According to Philips, the defect in the products that lead to the recall is related to the polyester-based polyurethane (PE-PUR) sound abatement foam material used in the devices. When the devices are cleaned incorrectly or exposed to high heat and humidity, the foam can disintegrate into particles. There is a risk of these toxic particles entering the device’s air pathway and being ingested or inhaled by the users. 

Potential Foam Degradation

While there have not been any deaths linked to the PE-PUR foam disintegration yet, Philips acknowledged the potential risks of exposure to the foam particles. Phillips also recognized that the foam may off-gas certain chemicals. Headaches, irritation, inflammation, hypersensitivity, nausea/vomiting, respiratory issues and possible toxic and carcinogenic effects were all concerning symptoms that led to the recall.

The medical device company announced plans to replace the current sound-abatement foam with new, non-toxic material. 

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing to ensure patient safety,” said Philips CEO Frans van Houten. “We are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices.” 

Affected Devices

It is estimated that between 3 million and 4 million devices will be affected by the recall. Philips’ company spokesman Steve Klink stated that approximately 80% of the affected machines are CPAP machines, which treat people suffering from sleep apnea. The remaining 20% of the recalled machines are ventilators. 

The recalled devices include the following. All recalled units were manufactured before April, 26 2021 and all device serial numbers are affected. 

Philips’ Noncontinuous Ventilators
  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go Dorma 400
  • Dorma 500 REMstar SE Auto
Philips’ Continuous Ventilators 
  • Trilogy 100
  • Trilogy 200
  • Garbin Puls, Aeris, LifeVent
Philip’s Continuous Ventilator, Minimum Ventilatory Support, Facility Use 
  • A-Series BiPAP Hybrid A30 (not marketed in the US)
  • A-Series BiPap V30 Auto 
Philips’ Continuous Ventilator, Non-life supporting 
  • A-Series BiPAP A40 (not marketed in the US) 
  • A-series BiPAP A30 (not marketed in the US) 
Philips DreamStation CPAP Machines 
  • DreamStation
  • DreamStation ASV
  • DreamStation GoDorma 400 
  • DreamStation ST, AVAPS 

Devices NOT Affected by the Recall at this Time

It’s important to note which machines were not recalled and are currently still safe for patient use. The following Philips machines are not affected by the current Philips recall: 

  • Trilogy Evo 
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL 
  • BiPAP A40 Pro 
  • M-Series 
  • DreamStation 2
  • Omnilab (original based on Harmony 2)
  • Dorma 100, Dorma 200 & REMStar SE 
  • All oxygen concentrators, respiratory drug delivery products and airway clearance products. 

Advice for Patients and Customers 

It is important to take steps to prevent any further damage caused by the recalled devices. Philips advises those using the now-recalled products to take the following actions: 

  • For patients using affected BiLevel PAP and CPAP devices:

Discontinue the use of your device and work with your physician or durable medical equipment (DME) provider to determine the most appropriate options for continued treatment. To continue the use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with the affected device outweighs the risks identified in the recall notification. 

  • For patients using affected life-sustaining mechanical ventilator devices: 

Do not stop or alter your prescribed therapy until you have talked with your physician. Philips recognizes that alternative ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification. 

Consult a Medical Device Liability Attorney

Under federal regulation, consumers are entitled to a level of safety from the manufacturers of the products they buy, especially when these products are marketed to enhance an individual’s quality of life. If you or someone you love has used or been affected by a recalled Philips Bi-Level PAP or CPAP machine, you may be entitled to compensation through a class action lawsuit. Consult with an experienced Medical Device Liability attorney at Sullivan Papain McGrath Coffinas and Cannavo P.C by calling 212-732-9000 or filling out the form below. for your free consultation. 

Sources for this article were gathered from USA Today, the American Association of Sleep Medicine, and Philips. 

 

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