LTV 29663-001Recalls & reported problems
Vyaire Medical, Inc. · Patient Circuit W/O PEEP, W/1 Water Trap, 22mm, SPU · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752115989), received between Sep 17, 2021 and Sep 17, 2021 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Connection 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.
InjurySep 17, 2021Connection Problem; Connection Problem
THE CUSTOMER REPORTED THAT THE PATIENT CIRCUIT W/O PEEP W/WATER TRAP, 22 MM SPU (10/PKG) EXPERIENCED GETTING CONNECTION ERROR. FOUND THE PART THAT CONNECTS TO VENT WAS DEFECTED OR INCORRECT CONNECTION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. AS AN INTERVENTION, THEY REPLACED THE SAMPLE AND IT WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12490590 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.