VixOne 0210Recalls & reported problems
Westmed, Inc. · Small Volume Nebulizer · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00709078000409), received between Nov 19, 2022 and Nov 1, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Connection Problem1
- Failure to Deliver1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Respiratory Problem2
- Respiratory Insufficiency1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2023Material Integrity Problem; Material Integrity Problem
WHEN THE NEBULIZER STARTED, IT DID NOT NEBULIZE MEDICATION.
Patient problems: Respiratory Insufficiency
MAUDE report 18051735 ↗MalfunctionOct 11, 2023Material Integrity Problem; Material Integrity Problem
BLUE PIECE OF NEBULIZER FALLS OFF WHEN PACKAGE IS OPENED.TREATMENT DELAYED UP TO 15 MINUTES.
Patient problems: Unspecified Respiratory Problem
MAUDE report 17914134 ↗MalfunctionJul 12, 2023Connection Problem; Connection Problem
TUBING BECOMES DISCONNECTED FROM THE VENTILATOR.
Patient problems: Unspecified Respiratory Problem
MAUDE report 17312277 ↗MalfunctionDec 1, 2022Failure to Deliver; Failure to Deliver
WILL NOT NEBULIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15896826 ↗MalfunctionNov 19, 2022Mechanical Problem; Mechanical Problem
NEBULIZER FAILURES (MEDICATION BUBBLES BUT NOT AEROSOL AND TUBE POPPING OFF).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15829743 ↗
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
- Portex Z110-14Icu Medical, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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