Tuesday, June 18, 2024

Sample Lines Recall: Vyaire Medical Faces FDA Class I Classification for Serious Risks

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Twin Tube sample lines from Vyaire Medical, a Germany-based medical device company, have faced a challenging year with the US Food and Drug Administration (FDA) classifying two of its recalls as Class I, the most serious type of recall indicating that the continued use of a device could result in serious injury or death. The latest recall involves 649 units of the company’s Twin Tube sample lines used in the Vyntus CPX cardiopulmonary exercise test (CPET) system, distributed between January 2015 and June 2023.

The Twin Tube sample lines collect gas samples from patients using the Vyntus CPX system, which measures oxygen and carbon dioxide levels from inhalations and exhalations to provide critical lung function data. These sample lines contain a drying hose designed to protect the gas sensors from moisture. However, the recall was initiated because a nozzle within the tube can detach and fall into the patient’s mouth, posing risks of choking and airway obstruction. Despite the severity of a Class I recall, Vyaire has reported no injuries or deaths related to this issue. The company has asked customers to identify faulty sample lines devices and perform a “pull-out test” to ensure the nozzle is securely attached.

Vyaire Faces Another Major Recall with Twin Tube Sample Lines Following Earlier Resuscitator Issues

This is not the first major recall Vyaire has faced this year. In March, the company recalled over six and a half million manual resuscitators from its AirLife range due to a manufacturing defect. This defect resulted in patients potentially not receiving sufficient ventilation, leading to hypoventilation or hypoxia. The recall followed reports of 37 incidents, including two injuries and two deaths.

The repeated recalls have posed significant challenges for Vyaire’s chief executive officer, John Bibb, who took on the role exactly one year ago. The recalls have also impacted the financial performance of the company. Investment firm Apax Global Alpha, which includes Vyaire in its portfolio, reported a decline in its Q1 2024 earnings due to Vyaire’s underperformance. The company’s struggles highlight the critical importance of stringent quality control measures in the medical device industry, especially for devices that play vital roles in patient care.

In the latest recall, the FDA highlighted the risks associated with the Twin Tube sample lines, emphasizing the potential for choking and airway obstruction due to the detaching nozzle. The sample lines recall affects a significant number of devices distributed over eight years, indicating a long-standing issue that has only recently come to light. Vyaire’s response has been to engage with customers directly, requesting them to perform tests to identify and mitigate the risks associated with the faulty sample lines tubes.

Sample Lines

Twin Tube Recall Follows Initial Class I Recall of Vyaire’s Manual Resuscitators Due to Severe Risks

The initial Class I recall earlier this year involved Vyaire’s manual resuscitators, crucial devices used in emergency and critical care settings. The manufacturing defect in these resuscitators could lead to severe consequences, including inadequate ventilation of patients. The recall was prompted by multiple reports of adverse events, which included two deaths, highlighting the high stakes involved in the medical device industry.

For John Bibb, navigating these recalls has been a significant test of his leadership. Promoted to CEO just a year ago, Bibb has had to manage the fallout from these recalls, ensuring that the company responds effectively to regulatory requirements while maintaining customer trust and safety. The financial impact of these recalls has also been considerable, with Apax Global Alpha noting a hit to its earnings due to Vyaire’s performance issues.

Overall, Vyaire Medical’s recent recalls underscore the critical importance of quality control and rigorous testing in the medical device industry. The potential risks associated with device failures are significant, and regulatory oversight by bodies like the FDA plays a crucial role in ensuring patient safety. As Vyaire continues to address these challenges, the company’s ability to implement effective corrective actions and prevent future issues will be closely watched by the industry and regulators alike. The outcome of these efforts will not only affect the company’s reputation and financial health but also the safety and well-being of the patients who rely on its devices.

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Resource: Food and Drug Administration, May 23, 2024

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