N/A 1030Recalls & reported problems
Galemed Corporation · 12.5 cmH2O Pressure Relief Manifold · Class 2
- 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.
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.
Recalls naming this device
- May 30, 2019Terminated
Reports of pressure relief manifold venting gas below the standard pressure.
Z-0020-2020 · Root cause: Device Design · FDA record ↗
Other Attachment, Breathing, Positive End Expiratory Pressure devices
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- VentStar Resuscitaire CEU MP00310Drägerwerk AG & Co. KGaA · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- WaterPAP™ WP-7700Sunmed, LLC · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
- Pneupac 100/905/340-CHIcu Medical, Inc. · Attachment, breathing, positive end expiratory pressure18 reports
- Shiley 125139Covidien LP · Attachment, breathing, positive end expiratory pressure1 death6 reports
- Shiley 125137Covidien LP · Attachment, breathing, positive end expiratory pressure4 reports
- Pneupac 100/905/340Icu Medical, Inc. · Attachment, breathing, positive end expiratory pressure3 reports
- Curaplex MRIPEEP-ABound Tree Medical, LLC · Attachment, breathing, positive end expiratory pressure1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.