The Astral 100 and Astral 150 ventilators provide continuous or intermittent ventilatory support for patients weighing more than 5 kg who require mechanical ventilation, the FDA reports. The ventilators are intended for use in home, institutional/hospital, and portable settings for both invasive and noninvasive ventilation.

In a subset of Astral 100 and Astral 150 ventilators, Resmed has identified that a component (called a “supercapacitor”) may leak over time. The leakage may damage specific circuitry on the printed circuit board assembly. This can result in the ventilator inadvertently entering a fail-safe state and being unable to deliver therapy. Patients who are unable to maintain spontaneous ventilation, or who do not have access to adequate monitoring or alternative ventilation, may be at risk of serious injury or death if the fail-safe state is entered and therapy is not restored.

As of June 23, Resmed has reported five serious injuries and no deaths associated with this issue, the FDA says.

According to the FDA, patients should not stop using the ventilator unless they are instructed by their clinician.

Affected Devices:

  • Astral 100 ventilators built prior to October 2024
    • Serial Number: less than 22241890149
    • Unique Device Identifier (UDI): 00619498003259, 00619498270019
  • Astral 150 ventilators built prior to October 2024
    • Serial Number: less than 22241890149
    • Unique Device Identifier (UDI): 00619498270033
  • Astral 100 PCBA spare parts built prior to October 2024
    • Characters 2–8 on the PCBA or ventilator user interface are less than 2707658
    • Unique Device Identifier (UDI): 00619498290512
  • Astral 150 PCBA spare parts built prior to October 2024
    • Box Serial Number: less than 22241978070
    • Unique Device Identifier (UDI): 00619498290529

FDA Recommendations for Healthcare Providers

  • Check all ventilators to determine whether the main board currently installed is affected by this issue. If a ventilator has previously had its PCBA replaced, the replacement PCBA should be verified. Ventilators fitted with a main board that is not affected by this issue are not impacted.
  • Immediately provide a copy of this notice, together with the physician letter and patient/carer communication, to all relevant healthcare professionals, patients, and carers. 
  • Reinforce adherence to the Astral User Guide and Clinical Guide instructions, including ensuring that ventilator-dependent patients are appropriately monitored, that care providers are trained and confident in responding to ventilator alarms and emergency situations, and that appropriate alternative ventilation equipment is functional, regularly checked, and immediately available where required. 
  • Do not remove an affected ventilator from use unless an appropriate alternative means of ventilation is immediately available. If an affected ventilator becomes inoperable, it should be removed from use and replaced with an appropriate alternative means of ventilation. Patients should continue therapy unless otherwise directed by their treating clinician. 
  • Review and assess the affected patients’ clinical needs and their clinical risk category (Tier 1, Tier 2 or Tier 3) using Appendix A (provided in Resmed’s health care provider letter) and clinical judgement. 
  • Arrange inspection of affected ventilators in accordance with the Phase 1 Inspection and Correction Strategy in Appendix A. Return ventilators to an authorized service center when required. 
  • Continue to follow Resmed service and maintenance processes, including the 2-year preventative maintenance schedules and current Technical Service instructions (including Tech Note 1063720 and subsequent updates). 
  • Identify affected ventilators within your control and review the serial number list provided by Resmed. 
  • Monitor communications from Resmed regarding this issue. Resmed will provide further updates and instructions directly to affected customers via email or other appropriate communication channels as additional information becomes available. 
  • For new patients, prioritize alternative ventilator options due to the significantly constrained availability of Astral ventilators.

More information is available at the FDA website.