Ventlab VR2100-20Recalls & reported problems
Ventlab, LLC · INFANT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483111499), received between Aug 15, 2025 and Aug 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT THE MASKS DID NOT INFLATE. WHILE NO HARM OR INJURY WAS REPORT, THE MASK NOT INFLATING WOULD DELAY THERAPY OR TREATMENT AND COULD CAUSE HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22822410 ↗
Other MASK, GAS, ANESTHETIC devices
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- Ventlab BT4045Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT2034Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT3034Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4024Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4013Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4019Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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