Percussionaire Corporation: 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

Recall number

Z-0031-2026

Recalling firm

Percussionaire Corporation

Product

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

Status

Open, Classified

Initiated

2025-09-17

Posted

2025-10-14

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

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: FSCA@sentec.com

Quantity

59160

Distribution

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

Lot, serial or model codes

UDI-DI: 00849436000723. Lots: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756. Instructions for Use P20020 Rev F

510(k) numbers

not on file

PMA numbers

not on file

Product code

BZO

Firm FEI

1000524541

Firm city

Sandpoint

Firm state

ID

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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