Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use
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: Twin Tube
- Product Codes: BZC
- Model Numbers: V-707327
- Distribution Dates: January 1, 2015 to June 30, 2023
- Devices Recalled in the U.S.: 649
- Date Initiated by Firm: April 8, 2024
Device Use
The Twin Tube sample lines play a central role in the Vyntus CPX system. These tubes connect to the dead volume trap (DVT) adapter, allowing for the continuous collection of gas samples from the test subject's breath during Cardiopulmonary Exercise Testing (CPET) measurements. Integrated within the Twin Tubes is a drying hose, which removes moisture from the gas samples to protect the integrity of the gas sensors. These sensors, housed within the device, analyze oxygen (O2) and carbon dioxide (CO2) levels throughout the patient's inhalation and exhalation during exercise, providing valuable pulmonary (lung) function data.
Reason for Recall
Vyaire Medical, Inc. is recalling the Twin Tube due to the potential of the nozzle separating during patient use. The separated component may fall into the patient’s mouth resulting in a potential choking hazard which may lead to an airway obstruction, requiring medical intervention to prevent further injury or harm.
There have been no reports of injuries or deaths associated with this issue.
Who May be Affected
- Health care Professionals who use the Twin Tube
- Patients who have undergone testing or treatment involving the Twin Tube
What to Do
On April 8, 2024, Vyaire Medical, Inc. sent all affected customers an URGENT Field Safety Notice.
The letter requested customers to:
- Confirm receipt and thoroughly review the contents of the Customer Notification Package which includes this notice and the Distributor/End-User Response Form. Share this information anywhere products may have been forwarded.
- Perform a physical inventory inspection to identify and isolate potentially affected devices.
- Perform the Pull-out Test on all current inventory on-hand as described in Appendix A, “Pull‐out Test”, to verify the adhesive is adequate prior to use.
- Complete the Distributor/End-User Response Form and return to GMB‐EMEAFSCA‐RDX‐INTL@Vyaire.com. The email subject line should be labeled “Response Form: FSCA‐24‐002‐FSN‐1".
Contact Information
Customers in the U.S. with questions about this recall should contact Vyaire Medical, Inc. at GMBEMEA‐FSCA‐RDX‐INTL@Vyaire.com.
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.