Vital Signs™ 1552018Recalls & reported problems
Vyaire Medical, Inc. · Vital Signs™ Pediatric Anethesia Breathing Circuit · 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 10190752118201), received between Apr 4, 2025 and Apr 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection 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
- Connection Problem1
- Disconnection1
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.
MalfunctionApr 4, 2025Disconnection; Connection Problem; Disconnection; Connection Problem
IT WAS REPORTED THAT TWO DIFFERENT DEVICES DURING USE THE ETCO2 PIGTAIL COMES OFF THE HME. TWO SEPARATE REPORTS WILL BE SUBMITTED. THE FIRST REPORT NUMBER IS 8030673-2025-00014.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21780691 ↗
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- Medline Industries, Inc. ACC010540Medline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)2 recalls0 reports
- Medline Industries, Inc. DYKMBNDL199AMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)2 recalls0 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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