Percussionaire P5-TEE In-Line Valve labeling updated for anesthetic delivery safety risk
What this means
Percussionaire Corporation has updated labeling for its P5-TEE In-Line Valve to warn against using it with volatile anesthetic delivery systems. When used together, the valve may interfere with anesthetic control, potentially causing unintended deeper or lighter anesthesia, heart rate changes, elevated pressure in the brain, or awareness during anesthesia.
- If you use this valve in an operating room or anesthesia setting, review the updated labeling immediately.
- Do not use the P5-TEE valve in conjunction with volatile anesthetic delivery systems.
- Contact Percussionaire Corporation or your equipment supplier with questions about safe use.
The agency's original wording
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3320-2026More Percussionaire recalls
- FDA-Device2026-10-07Percussionaire IPV 1 and Phasitron 5 ventilators need updated anesthetic safety instructions
- FDA-Device2026-10-07Percussionaire IPV-1C and Phasitron 5 ventilators need updated anesthetic safety warning
- FDA-Device2026-10-07Percussionaire Travel Air and Phasitron 5 ventilators need updated anesthetic safety warning
- FDA-Device2026-10-07Percussionaire Impulsator and Phasitron 5 IPV devices need updated anesthetic safety instructions
- FDA-Device2026-10-07Percussionaire IPV-2C and Phasitron 5 ventilators need updated anesthetic safety warning
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