INNSOPIRE GO Europe1ROW 00Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · INNSOPIRE GO Europe1ROW · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00383730000534), received between Dec 4, 2023 and Dec 18, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Corroded” (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
- Corroded2
- Unexpected Shutdown2
- Failure to Power Up1
- Insufficient Flow or Under Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2023Corroded; Corroded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A INNOSPIRE GO DEVICE HAS OXIDIZED CHARGING PORTS. 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 18349841 ↗MalfunctionDec 6, 2023Corroded; Corroded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A INNOSPIRE GO DEVICE HAD CORROSION ON THE POWER CORD. 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 18279571 ↗MalfunctionDec 4, 2023Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A INNOSPIRE GO DEVICE IS PROVIDING SMALL DOSES AND STOPS AFTER A SHORT RUN. 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 18258628 ↗MalfunctionDec 4, 2023Insufficient Flow or Under Infusion; Unexpected Shutdown; Insufficient Flow or Under Infusion; Unexpected Shutdown
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A INNOSPIRE GO DEVICE IS PROVIDING SMALL DOSES AND STOPS AFTER A SHORT RUN. 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 18258223 ↗
Other NEBULIZER (DIRECT PATIENT INTERFACE) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- 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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