INNOSPIRE GO AUNZ 00Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · INNOSPIRE GO AUNZ · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383730004389), received between Oct 20, 2021 and Jan 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (1 report).
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
- Charging Problem1
- Failure to Run on Battery1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2024Failure to Run on Battery; Failure to Run on Battery
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE CUSTOMER REPORTED THAT THEIR BATTERY STOPPED CHARGING AND WILL ONLY WORK PULLED INTO THE CHARGING CABLE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18450231 ↗MalfunctionOct 20, 2021Charging Problem; Charging Problem
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A CHILD USER WAS PLUGGING THE CHARGER INTO THE WALL OUTLET AND THE BASE OF THE INNOSPIRE GO BECAME DETACHED. NO HARM OR INJURY WAS REPORTED. THE MANUFACTURER HAS REQUESTED RETURN OF THE DEVICE AND ALL ACCESSORIES THAT WERE IN USE AT THE TIME OF THE EVENT, AND THE INVESTIGATION IS ON-GOING. ON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12668949 ↗
Other NEBULIZER (DIRECT PATIENT INTERFACE) devices
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- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
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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