Vivo Series 006093Recalls & reported problems
Breas Medical AB · MPV circuit 2 pcs · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Oct 13, 2023Class IIOpen, Classified
Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
Z-0405-2024 · Root cause: Process control · Recall details · FDA record ↗
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
- ID Coax 180 MP03375Drägerwerk AG & Co. KGaA · 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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