INNOSPIRE GO AMERICAS 00Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · INNOSPIRE GO AMERICAS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00383730002446), received between Nov 21, 2023 and Apr 30, 2025 — classified as 1 death, 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Failure to Deliver1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Dyspnea1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Failure to Deliver; Failure to Deliver
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A USER OF AN INNOSPIRE GO DEVICE REPORTS IT IS NOT WORKING. THE PATIENT REPORTS THE DEVICE IS NOT NEBULIZING THE MEDICATION AND THE LIGHT IS BLINKING ON THEN OFF. THE NEBULIZER WAS RINSED OUT WITH WATER IN THE MEDICINE CUP AND PLUGGED INTO THE WALL. AFTERWARDS THE LIGHT IS NO LONGER BLINKING AND STILL NO MIST IS COMING OUT. 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 21939564 ↗DeathJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INNOSPIRE GO CONTROL HEAD THE MANUFACTURER RECEIVED INFORMATION FROM THE RELATIVE OF A PATIENT IN REFERENCE TO AN INNOSPIRE GO DEVICE. THE PATIENT PASSED AWAY ON AN UNSPECIFIED DATE IN 2022. THE PATIENT'S CAUSE OF DEATH WAS NOT PROVIDED BY THE REPORTER. THE REPORTER STATED THE CONTROL HEAD ON THE DEVICE WAS IN NEED OF REPLACEMENT.
Patient problems: Insufficient Information
MAUDE report 19782024 ↗InjuryJul 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN INNOSPIRE GO DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS COMING APART, DESCRIBED AS, "THE BOTTOM OF THE DEVICE IS TOTALLY DISCONNECTED FROM THE OTHER PART". MEDICAL INTERVENTION WAS DESCRIBED AS THE PATIENT VISITED URGENT CARE IN APRIL TO SEEK A BREATHING TREATMENT DUE TO THE NEBULIZER "WOULDN'T COME ON". THE PATIENT'S CURRENT CONDITION IS STABLE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Dyspnea
MAUDE report 19654408 ↗MalfunctionNov 21, 2023Failure to Power Up; Failure to Power Up
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN INNOSPIRE GO NEBULIZER WITH INFORMATION ALLEGING THE DEVICE WOULD NOT TURN ON. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. A NEBULIZER DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE SERVICE TECHNICIAN CONFIRMED THE DEVICE HAD NO POWER AND WOULD NOT TURN ON. 1. PIL VISUALLY INSPECTED THE INNOSPIRE GO FOR OBVIOUS DEFECTS FINDING CORROSION ON ALL CONNECTION PINS. NO PHYSICAL DAMAGE TO THE DEVICE OR POWER SUPPLY, NORMAL WEAR, AND TEAR. THE CHARGER CAME IN WITH THE DEVICE. 2. THE DEVICE HAS MILD ENVIRONMENTAL CONTAMINATION BUILT UP THROUGHOUT THE MEDICINE DELIVERY PORT, AIR INLET, AND MOUTHPIECE. THE PIL FOUND CORROSION ON BOTH SETS OF THE DEVICE'S 2-PRONG CHARGING PINS FOR THE CHARGER TO MOUTHPIECE. PIL APPLIED AC POWER THOUGH POWER SUPPLY SENT. DEVICE WILL NOT CHARGE OR POWER ON. 3. PIL TESTED THE POWER SUPPLY/CHARGER THAT CAME IN WITH THE DEVICE FOR VOLTAGE AND RESISTANCE, READING 0V AND OPENED READING FOR POWER SUPPLY/CHARGER. THE DEVICE APPEARS TO HAVE POSSIBLE INGRESS ISSUES SHOWING CORROSION ON ALL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18179605 ↗
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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