VentStar Bag Set (P) 110 MP00384Recalls & reported problems
Drägerwerk AG & Co. KGaA · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier.
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.
Recalls naming this device
- Apr 17, 2023Terminated
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Z-1445-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 17, 2023Terminated
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Z-1446-2023 · Root cause: Process control · Recall details · FDA record ↗
Other Bag, Reservoir devices
- VentStar Bag Set (N) 110 MP00383Drägerwerk AG & Co. KGaA · Bag, Reservoir1 recall0 reports
- Portex 101/870/070CZIcu Medical, Inc. · BAG, RESERVOIR28 reports
- WalkMed® 204821Walkmed Technologies, LLC · Bag, Reservoir4 reports
- Portex C45031768D-NLIcu Medical, Inc. · BAG, RESERVOIR3 reports
- CARDINAL HEALTH BB3000LFBCardinal Health 200, LLC · BAG, RESERVOIR2 reports
- Portex C37201370JIcu Medical, Inc. · BAG, RESERVOIR2 reports
- Portex C49201668D-NLIcu Medical, Inc. · BAG, RESERVOIR2 reports
- WalkMed® 204822Walkmed Technologies, LLC · Bag, Reservoir1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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