AstralRecalls & reported problems across all models
Resmed Pty Ltd · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Astral model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,253
- Deaths reported
- 26
- Injuries reported
- 31
- Recalls
- 1
We found 3 models of Astral by Resmed Pty Ltd in the FDA's device registry (GUDID). Together they are named in 3,253 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2016 and Sep 29, 2026 — classified as 26 deaths, 31 injuries, 3,196 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (1,090 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Astral recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 25, 2026Open, Classified
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Z-2735-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported Astral problems
Device problems
- Protective Measures Problem1,090
- Battery Problem611
- Failure to Calibrate427
- Device Displays Incorrect Message354
- Failure to Charge213
- Inadequate User Interface180
- Display or Visual Feedback Problem171
- Failure of Device to Self-Test166
Patient problems
- No Clinical Signs, Symptoms or Conditions1,615
- No Consequences Or Impact To Patient1,239
- Insufficient Information187
- No Patient Involvement163
- Low Oxygen Saturation13
- Death10
- Loss of consciousness9
- Respiratory Distress4
Astral models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Astral 150Continuous, Ventilator, Home Use1 recall17 deaths2,361 reports
- Astral 100Continuous, Ventilator, Home Use9 deaths865 reports
- ASTRAL 27919Continuous, Ventilator, Home Use27 reports
Recent Astral adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Protective Measures Problem
During Resmed evaluation, an Astral device displayed an error message (SF140) related to alarm priority. There was no harm or serious injury reported as a result of the incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927463 ↗MalfunctionSep 29, 2026Protective Measures Problem
During Resmed evaluation, an Astral device displayed an error message (SF140) related to alarm priority. There was no harm or serious injury reported as a result of the incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927462 ↗MalfunctionSep 29, 2026Protective Measures Problem
It was reported to Resmed that an Astral device displayed an error message (SF140) related to alarm priority. There was no harm or serious injury reported as a result of the incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927431 ↗MalfunctionSep 29, 2026Protective Measures Problem
It was reported to Resmed that an Astral device displayed an error message (SF140) related to alarm priority. There was no harm or serious injury reported as a result of the incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927430 ↗DeathAug 28, 2026No Audible Alarm
It was reported to Resmed that a patient expired while using an Astral 100 device. It was reported that the patient became unresponsive while receiving ventilatory support from the device and no alarms were reportedly heard by the caregivers at the time of the event. The mother called for assistance, and family members initiated CPR prior to the arrival of emergency responders. Upon arrival of emergency responders, they assumed resuscitation efforts, and transported the patient by ambulance to a hospital, after which the patient was transferred to another hospital for a higher level of care. The patient was pronounced deceased at the hospital.
Patient problems: Loss of consciousness
MAUDE report 50505593 ↗DeathAug 28, 2026No Audible Alarm
Patient problems: Loss of consciousness
MAUDE report 50505590 ↗InjuryAug 19, 2026Use of Device Problem
It was reported to Resmed that an Astral device displayed a 'low pressure' alarm while in use. Learn Circuit was performed and the device displayed 'without SpO2 monitoring'. The patient was placed on a different device. The patient's SpO2 was 88% and manual ventilation was provided.
Patient problems: Low Oxygen Saturation
MAUDE report 50332128 ↗MalfunctionJun 26, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF179) RELATED TO A SUPER CAPACITOR ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641921 ↗MalfunctionJun 26, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF179) RELATED TO A SUPER CAPACITOR ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641777 ↗MalfunctionJun 23, 2026Battery Problem; Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A BATTERY ERROR MESSAGE. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25603117 ↗MalfunctionJun 23, 2026Battery Problem; Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A BATTERY ERROR MESSAGE. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25603104 ↗MalfunctionJun 22, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. DURING EVALUATION, THE DEVICE DISPLAYED ERROR MESSAGE (SF140) RELATED TO ALARM PRIORITY AND ERROR MESSAGE (SF 82) RELATED TO THE HARDWARE ALARM CONTROLLER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25588369 ↗MalfunctionJun 10, 2026Failure to Power Up
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462712 ↗MalfunctionJun 10, 2026Failure to Power Up
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462695 ↗MalfunctionJun 8, 2026Battery Problem
DURING RESMED EVALUATION, AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM AND FAILED TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25423216 ↗
Other Resmed Pty Ltd products
- AIRFIT F30I10 models · 4 reports · 1 recall
- AIRFIT N 107 models · 0 reports · 1 recall
- AIRFIT N2013 models · 0 reports · 1 recall
- AirTouch F2016 models · 0 reports · 1 recall
- AirFit F305 models · 0 reports · 1 recall
- AirTouch N209 models · 0 reports · 1 recall
- AIRFIT F2012 models · 0 reports · 1 recall
- AIRSENSE5 models · 44 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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