FDA alerts to Class I recall of Twin Tube by Vyaire Medical, Inc. due to risk of malfunction, choking hazard

According to the FDA, Vyaire Medical, Inc.’s April 8, 2024, recall of its Twin Tube has been identified as Class I, the most serious type, because use of the product could lead to major injuries or death.

The recall, which was updated on May 23, 2024, covers 649 devices that were distributed across the U.S. from January 1, 2015 to June 30, 2023. All affected Twin Tubes can be found under product code BZC and model number V-707327.

As the main component of the firm’s Vyntus CPX system, the Twin Tube sample lines connect to the dead volume trap (DVT) adapter, which allows healthcare professionals to continuously collect gas samples from a patient’s breath while taking Cardiopulmonary Exercise Testing (CPET) measurements. A drying hose within the Twin Tubes facilitates the removal of moisture from the gas samples to safeguard the functioning of the gas sensors. The sensors in the device then are able to assess the levels of oxygen (O2) and carbon dioxide (CO2) produced by a patient’s inhalation and exhalation during exercise activity. The data collected could reveal valuable information about a patient’s pulmonary (lung) function.

Officials took action after being made aware that the nozzle of the Twin Tube could potentially separate during patient use and result in a choking hazard that obstructs the airway. In such an event, immediate medical intervention would be required in order to prevent continued harm to the patient.

While Vyaire Medical, Inc. has not received any reports of injury or death associated with the recall, healthcare professionals who administer the Twin Tube, as well as patients whose testing or treatment involve the device, are advised that they could be impacted.

A communication labeled “Urgent Field Safety Notice” was sent to all of Vyaire Medical, Inc.’s affected customers on April 8, 2024. The following requests were made:

  • Carefully review all content provided in the Customer Notification Package, which includes the notice and the Distributor/End-User Response Form. The information in the package should also be shared with anyone else who may have received the products.
  • Fully inspect the facility’s physical inventory to identify and quarantine any devices that may be affected by the recall.
  • As described in Appendix A, conduct the Pull-out Test on all current inventory to ensure that the adhesive is adequate before each use of the device.
  • After completing the Distributor/End-User Response Form, have it returned via email to GMB‐EMEAFSCA‐RDX‐INTL@Vyaire.com with the subject line “Response Form:FSCA‐24‐002‐FSN‐1”.

Additional questions about the U.S. recall may be directed to Vyaire Medical, Inc. via GMBEMEA‐FSCA‐RDX‐INTL@Vyaire.com.

As the FDA continues to monitor this recall, healthcare providers and consumers are encouraged to report any adverse reactions or quality issues to the agency’s MedWatch Adverse Event Reporting program.


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