This recall involves removing certain devices 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.

On October 3, 2024, Percussionaire sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

Percussionaire is recalling certain lots of Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one of the circuit's components. The nickel coating may react to combinations of saline mixed with albuterol and/or N-acetylcysteine causing both discoloration and the potential to aerosolize the nickel during normal clinical use, which may expose patients to higher than expected levels of nickel.

The use of affected products may cause serious adverse health consequences, including lung injury from inflammation, severe airway narrowing (bronchospasm), lower immunity (humoral immunity), allergic reactions, and death.

There have been three reported injuries. There have been no reports of death.

The Intrapulmonary Percussive Ventilation (IPV) Phasitron 5 breathing circuit is part of the Phasitron 5 system that provides IPV therapy to patients who are receiving mechanical ventilation to help them breathe. This type of therapy can improve gas exchange and help keep the airways clear during ventilation.

Customers in the U.S. with questions about this recall should contact [email protected].

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.

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