CPAP and BiPAP Recalls

Sleep Apnea and CPAP/BiPAP Machines

Each year, more than 22 million Americans are affected by a sleeping disorder called sleep apnea. Sleep apnea happens when breathing stops and starts throughout the night and it can be potentially life threatening. When breathing stops, the lack of oxygen drops the heart rate. Instinctively, the body will startle itself awake to begin breathing again; however, in doing so the heart rate rises quickly which then increases blood pressure. Higher blood pressure over time stresses the heart muscles and can lead to life-threatening issues over time. If left untreated, sleep apnea can cause:

  • High Blood Pressure
  • Stroke
  • Hypertension
  • Heat Attack
  • Heat Failure
  • Diabetes
  • Obesity
  • Arrhythmias
  • Cardiomyopathy 

While the risk of sleep apnea increases with age, it can occur at any period in life including childhood and infancy. Children who have larger tonsils may experience sleep apnea if the airway is blocked while they sleep. Adults with sleep apnea may notice the severity increase as they age, although the risk of development does decease after age 65.

Treatment

Treatment of sleep apnea is determined by its severity. The preferred method of treatment and perhaps the most common is the use of CPAP and BiPaP Machines. CPAP, which stands for Continuous Positive Airway Pressure. is a machine that keeps the air passageways open by delivering air pressure through the nostrils. This machine uses a tube and mask that fits over the face. BiPAP, which stands for Bi-Level Positive Airway Pressure, keeps air passageways open by delivering two pressures: inhale and exhale pressure. Both use the mask and tube system. CPAP generally treats obstructive sleep apnea, while BiPAP machines are used to treat central or complex sleep apnea, or COPD.

 

CPAP and BiPAP Recall

In June 2021, the FDA  announced recalls on BiPAP and CPAP machines made by Philips Respironics. To reduce sound and vibration, these devices contain a polyester-based polyurethane foam. This foam can break down releasing chemicals and small pieces of black foam that can be easily inhaled or ingested.

FROM THE FDA

Philips Respironics recalled devices made between 2009 and April 26, 2021. Additionally, Philips recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers.

  • 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)

Recommendations for those using recalled BiPAP and CPAP machines

 

Additionally, the breakdown of these devices may be linked to certain cancerous and non-cancerous conditions:

  • Leukemia
  • Breast Cancer
  • Lymphatic Cancer
  • Liver
  • Nasal
  • Non-Hodgkin’s Lymphoma
  • Lung
  • Brain
  • Multiple Myeloma
  • Prostate
  • Bladder
  • Testicular 
  • Stomach
  • Papillary Thyroid Carcinoma
  • Blood
  • Kidney
  • Spleen

Non- Cancer

  • Asthma
  • Pulmonary Edema
  • Pulmonary Fibrosis
  • Other Lung Disease
  • Hyper or Hypothyroid Disease
  • Liver Disease/Damage
  • Kidney Disease/Damage

 

Sources:
“Sleep Apnea”, Cleveland Clinic. (March 2020). [Link]
“Sleep Apnea Information for Clinicians,” American Sleep Apnea Association. [Link]
“Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication,” US Food and Drug Administration (March 14, 2022). [Link]
“CPAP and BiPAP: Which One is Best For You?,”American Sleep Association (2017). [Link]

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