Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive… recallZ-0031-2026 · Percussionaire Corporation · initiated Sep 17, 2025

Why it was recalled

IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

FDA root cause category: Device Design

What the company is doing

On 9/17/2025, correction notices were emailed to customers who were informed of future design update and current instructions for use update, and advised: If adequate exhaled tidal volumes cannot be achieved with the In-Line Valve in place, consider removing the IN-Line Valve from the circuit when IPV therapy is not being delivered or choose a different treatment configuration (e.g., direct to artificial airway). Insufficient exhaled tidal volumes may lead to hypoventilation. At initial placement of the In-Line Valve in the inspiratory limb: (either at the patient wye or on the dry side of the humidifier) Allow the ventilator to complete two or more cycles and adjust settings, if necessary, to compensate for any potential leaks and to ensure exhaled tidal volumes are adequate. At completion of IPV treatment when performed with In-Line Valve: 1) Close pressure relief adjustment valve and turn off IPV device in quick succession. 2) Restore ventilator settings noted before treatment and reassess the patient. 3) Allow the ventilator to complete two or more cycles and adjust settings, if necessary, to ensure exhaled tidal volumes are adequate. Warning: The In-Line Valve should not be used in neonates and infants who are at high risk of cardiopulmonary or neurological compromise due to unrecognized hypoventilation. Customers asked to do the following: 1) Print and post updated instructions for use throughout your facility. 2) Communicate and train primary users of IPV therapy. 3) Review instructional protocols and update as needed to conform to the updated instructions. 4) Re-label current product by placing the sticker provided by firm on each individual In-Line Valve bag in stock below the current product label. Distributors were asked to forward the notice to their customers. Questions can be directed to firm via email at: [email protected]

Recall details

Recall number

Z-0031-2026

Status

Open, Classified

Initiated by the company

Sep 17, 2025

Posted by the FDA

Oct 14, 2025

Recalling firm

Percussionaire Corporation

Quantity

59160

Product code

BZO

Distribution

Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE

Product description

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Percussionaire P5-TEE

  Percussionaire Corporation · Set, Tubing And Support, Ventilator (W Harness)
  2 recalls1 report