Breath syst 10mm HME & MR 3M Disp 6694145Recalls & reported problems
Maquet Critical Care AB · Class 1
Data updated Oct 18, 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 07325710002339), received between Mar 26, 2020 and Mar 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2020Break
WHEN ATTEMPTING TO CONNECT THE PATIENT TO THE VENTILATOR, IT WAS FOUND THE TUBING WAS MALFUNCTIONING AND WAS COMING APART.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9882678 ↗
Other Set, Tubing And Support, Ventilator (W Harness) devices
- Breathing circuit set, coaxial 260128Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)2 recalls10 reports
- Percussionaire P5-TEEPercussionaire Corporation · Set, Tubing And Support, Ventilator (W Harness)2 recalls1 report
- F&P FlexiTrunk BC191-05Fisher & Paykel Healthcare Limited · Set, Tubing And Support, Ventilator (W Harness)76 reports
- HUDSON RCI IPN043837Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall18 reports
- Breathing circuit set, coaxial 260127Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall7 reports
- Breathing circuit set, coaxial 260168Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall4 reports
- Breathing circuit set, coaxial 260167Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall3 reports
- Vivo Series 006093Breas Medical AB · Set, Tubing And Support, Ventilator (W Harness)1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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