IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure

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. 

Affected Product

• Product Names: Phasitron 5 breathing circuits 
• Part Numbers/Lot Numbers: 
  • P5-10/240329, 240412,240430, 240509, 240516, 240614, 240625 
  • P5-HC-5/240321
  • P5-UC-10/240627

What to Do

• Do not use products from affected lots.  
• If products from affected lots must be used because there are not replacement products available, be sure to follow the firm’s updated instructions, which include:
  • Rinse with sterile water after use and allow to air dry.
  • Only use saline as the liquid in the nebulization cup.
  • Stop use if unexpected symptoms occur.
• Do not:
  • Use to deliver medications
  • Use for longer than 14 days
  • Use on patients with an inflammatory state

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

• Dispose of all opened or used affected products. 
• Return all unopened, impacted products. 
• If short-term use of affected product is required, follow the instructions provided by the firm, which include: 
  • Rinsing with sterile water after use and air dry.
  • Only using saline in the nebulization cup.
  • Stopping use if unexpected symptoms occur.
  • Do not:
    • Use to deliver medications
    • Use for longer than 14 days
    • Use on patients with an inflammatory state
• Complete and return acknowledgement form included with the letter by October 18, 2024. 

Reason for Recall

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

Device Use 

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.

Contact Information

Customers in the U.S. with questions about this recall should contact FSCA@sentec.com.

Additional FDA Resources:

• Related FDA recall classification summary: IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug [10/02/2024] 
• 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 report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.