The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: High Frequency Transport Phasitron Breathing Circuit Kit (A50605-D)
- Product Codes: See Recall Database Entry
- Distribution Dates: June 9, 2023 to December 1, 2023
- Devices Recalled in the U.S.: 2,145
- Date Initiated by Firm: December 12, 2023
Device Use
The High Frequency Transport Phasitron Breathing Circuit Kit is used for continuous ventilation of patients. The kit is intended to be used with Percussionaire high frequency percussive ventilation (HFPV) systems for either hospital or prehospital use where emergency care is being provided. The kit can also be used for transport within a hospital or outside a hospital.
Reason for Recall
Percussionaire is recalling their High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization. There are two parts of the Phasitron kit that must be pressed together during manufacturing. If one part is angled incorrectly and pressed, the part can become deformed. This causes the PEEP (positive end expiratory pressure) valve to be stuck in the closed position. When the valve is stuck, there is no way to manually release the valve.
The use of the affected Phasitron kits may cause serious adverse health consequences, including lung injury, low blood pressure, collapsed lung, cardiac arrest, and death.
There have been three complaints regarding this device issue, and one injury. There have been no reports of death.
Who May be Affected
- People who are being ventilated with High Frequency Transport Phasitron Breathing Circuit Kits
- Health care providers who use High Frequency Transport Phasitron Breathing Circuit Kits to ventilate patients
What to Do
On December 12, 2023, Percussionaire sent all affected customers an Urgent Field Safety Notice to distributors and health care providers.
The letter requested distributors to:
- Complete and Return Distributor Acknowledgement form included along with Notice
- Send Urgent Field Safety Notice containing Pre‐Use Checklist to end customers
- Prioritize the return of affected lots in stock
- Support end customers returning affected products
The letter requested health care providers to:
- Complete and Return Acknowledgement form included along with Notice
- Complete Pre‐Check Checklist (included with Notice) prior to patient use
- Prioritize the return of all impacted product
Contact Information
Customers in the U.S. with questions about this recall should contact Percussionaire Corporation at 1-800-850-7205.
Full List of Affected Devices
A complete list of affected devices is available in the Medical Device Recalls database.
Additional Resources:
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 using an online form, regular mail, or FAX.
