INNOSPIRE MINI 00 (REF 1125473)Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · CUSTOM INNOSPIRE MINI MED4HOME, 6 pk. · 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 00383730003979), received between Oct 30, 2023 and Jul 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property 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
- Electrical /Electronic Property Problem1
- Failure to Power Up1
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.
MalfunctionJul 29, 2025Failure to Power Up; Failure to Power Up
THE MANUFACTURER RECEIVED INFORMATION A INNOSPIRE MINI DEVICE WILL NOT POWER ON. THE PATIENT STATES THE DEVICE HAS NOT POWERED ON SINCE THE DAY BEFORE. TROUBLESHOOTING WAS DONE BY UNPLUGGING THE POWER CORD/SUPPLY FROM THE OUTLET AND THE ISSUE WAS NOT RESOLVED. 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 22653379 ↗MalfunctionOct 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION THAT THE CUSTOMER'S NEBULIZER IS NOT WORKING. THE CUSTOMER STATED THAT THE SWITCH WAS BAD AND THAT HE MUST HOLD THE SWITCH DOWN AND FORWARD FOR THE COMPRESSOR TO FUNCTION. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. 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 18028495 ↗
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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