Percussionaire Corporation recalls Intrapulmonary Percussive Ventilation

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

Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual

On 8/18/2026, correction notices were emailed to customers and distributors who were informed of the following: The following warning will be added to associated Instructions for Use: Warning: Do not use IPV therapy in conjunction with volatile anesthetic delivery systems. The high-frequency percussive flow generated during IPV therapy may alter the controlled delivery of volatile anesthetic agents within the breathing circuit, resulting in unpredictable anesthetic agent concentrations that may result in serious patient harm. Note: Consult the anesthesia healthcare provider before disconnecting from the system if considering delivering IPV directly to the patient's airway. Customers were asked to do the following: 1) Print and post the new warning for applicable IPV devices throughout your facility to ensure adequate distribution of new information to users. 2) Reinforce adherence to the IPV User Guide and IPV Quick Reference Guide instructions, including ensuring communication and training primary users of IPV therapy, specifically those using it in-line with a ventilator, on the instructions and new warning. Distributors were asked to do the following: - Translate (if applicable) and send the Urgent Medical Device Field Safety Notice to affected end customers. -If the Distributor receives the signed acknowledgement letters from affected customers, please forward them and all related communication to FSCA@sentec.com. If there are any additional questions related to the updated instructions or other questions, please contact FSCA@sentec.com

• FDA enforcement recordOfficial FDA database entry for Z-3319-2026
• FDA device classification · NHJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5905The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Percussionaire CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
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Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.