Infant Flow SiPAP 27416-001 (UDI 10190752161917)Recalls & reported problems
Vyaire Medical, Inc. · KIT, SIPAP, IF, PLUS, AUX, MDISS, ENGLISH · 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 10190752161917), received between Apr 22, 2024 and Jun 28, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak1
- Incorrect Measurement1
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.
MalfunctionJun 28, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENT ALARMS WHEN PRESSURE REACHES 8CMH2O. FURTHERMORE, IT READS HIGHER THAN WHAT IS SET ON THE SCREEN. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19633002 ↗MalfunctionApr 22, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT AFTER PERFORMING THE ANNUAL PM THERE IS A CONSTANT LOUD LEAK AT THE BACK OF THE UNIT AT/NEAR THE EXHAUST TUBE.NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159766 ↗
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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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