Percussionaire Corp Issues Phasitron 5 In-Line Valve Correction, Updates Use Instructions

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This recall **involves updating instructions for using devices and does not involve removing them from where they are used or sold.* The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. This recall was classified on October 14, 2025.*

Affected Product

• Product Name: Phasitron 5 In-Line Valve
• UDI: 00849436000723
• Potential Lots Affected: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756

What to Do

On September 3, 2025, Percussionaire Corporation sent all affected customers an Urgent Medical Device Correction recommending the following actions:

• Review the updated instructions for proper in-line use and updated Instructions for Use (IFU).
• Print and post updated instructions for proper In-Line Valve use throughout your facility to ensure adequate distribution of new information to users.
• Communicate and train primary users of IPV therapy, specifically those using it in line with a ventilator, on the new instructions.
• Review institutional protocols related to P5-TEE in-line use and update as needed to conform to the updated instructions.

Reason for Correction

Percussionaire Corporation has identified a design limitation for the In-Line Valve (P5-TEE), where leaks can occur through the pressure relief valve, even if the valve is fully closed. The extent of the leak is dependent on the situation and often not clinically significant, but it can represent a substantive fraction of the intended ventilation for neonatal and infant patients with small tidal volumes. Leakage in the pressure relief valve provides a high risk of cardiopulmonary and neurological compromise due to a possibility of unrecognized hypoventilation, which could lead to respiratory acidosis, hypoxemia, or respiratory failure.

As of September 3, 2025 Percussionaire has reported four serious injuries and no deaths related to this issue.

Device Use

The IPV In-Line Valve is intended to be used to provide Intrapulmonary Percussive Ventilation (IPV) therapy to patients while assisted by Conventional Mechanical Ventilation using pressure-control, volume-control, SIMV-PC etc., when direct connection of IPV is not indicated.

Contact Information

Customers in the U.S. with questions about this recall should contact Percussionaire Corporation at 208-263-2549 or the Percussionaire/Sentec Customer Service department via email to FSCA@sentec.com.

Additional FDA Resources:

• FDA’s Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may r eport adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

• ## Content current as of:

04/15/2026

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