AIRCURVE 37307Recalls & reported problems
Resmed Pty Ltd · AIRCURVE 10 ST USA TRI · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00619498373079), received between Mar 31, 2026 and Mar 31, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Unexpected Shutdown” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected Shutdown2
Patient problems
- Low Oxygen Saturation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2026Unexpected Shutdown
IT WAS REPORTED TO RESMED THAT AN AIRCURVE 10 ST DEVICE UNEXPECTEDLY SHUT DOWN DURING USE ON A HOSPITALIZED HOSPICE PATIENT. IT WAS REPORTED THAT THE INTERRUPTION IN THERAPY RESULTED IN SIGNIFICANT OXYGEN DESATURATIONS. IT WAS REPORTED THAT THE PATIENT¿S DISCHARGE FROM THE HOSPITAL WAS DELAYED. THERAPY WAS CONTINUED USING A REPLACEMENT DEVICE.
Patient problems: Low Oxygen Saturation
MAUDE report 24747533 ↗InjuryMar 31, 2026Unexpected Shutdown
IT WAS REPORTED TO RESMED THAT AN AIRCURVE 10 ST DEVICE UNEXPECTEDLY SHUT DOWN DURING USE ON A HOSPITALIZED HOSPICE PATIENT. IT WAS REPORTED THAT THE INTERRUPTION IN THERAPY RESULTED IN SIGNIFICANT OXYGEN DESATURATIONS. IT WAS REPORTED THAT THE PATIENT¿S DISCHARGE FROM THE HOSPITAL WAS DELAYED. THERAPY WAS CONTINUED USING A REPLACEMENT DEVICE.
Patient problems: Low Oxygen Saturation
MAUDE report 24747532 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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