Vital Signs™ 8004515Recalls & reported problems
Vyaire Medical, Inc. · Patient Hytrel Tube, Adult, Reusable, 900 mm/ 35 in, connectors 22/22 mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752111653), received between Nov 4, 2022 and Aug 18, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
- Material Puncture/Hole1
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.
InjuryAug 18, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ANESTHESIOLOGIST HAD AN ISSUE IN TRANSFERRING TO MANUAL BAG MODE DURING PATIENT USE. THERE WAS A LEAK IN THE BREATHING SYSTEM. THE BAG HOSE HAD A PINHOLE. THEY HAD TO MANUALLY BAG THE PATIENT UNTIL ANOTHER MACHINE WAS PUT IN PLACE. FURTHERMORE, THERE IS NO HARM DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17573780 ↗MalfunctionNov 4, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8004515 - MANUAL VENT HOSE, REUSABLE, W BAG ARM WAS LEAKING DURING THE PROCEDURE. THERE WAS NO HARM REPORTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15737783 ↗
Other Anesthesia breathing circuit kit (adult & pediatric) devices
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- AirLife™ AH265Airlife · Anesthesia Breathing Circuit Kit (Adult & Pediatric)1 recall0 reports
- AirLife™ AH265Airlife · Anesthesia breathing circuit kit (adult & pediatric)1 recall0 reports
- Anesthesia Circuit Kit Coax HEPA MP17102Drägerwerk AG & Co. KGaA · Anesthesia Breathing Circuit Kit (Adult & Pediatric)1 recall0 reports
- Anesthesia Circuit Kit Coax 3 MP02732Drägerwerk AG & Co. KGaA · Anesthesia Breathing Circuit Kit (Adult & Pediatric)1 recall0 reports
- Anesthesia Circuit Kit Flex 6 MP02744Drägerwerk AG & Co. KGaA · Anesthesia Breathing Circuit Kit (Adult & Pediatric)6 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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