Breas Medical Announces Urgent Correction For Vivo 45 LS Ventilator

Breas Medical has begun a voluntary recall of its Vivo 45 LS ventilators due to the risk of increased exposure to harmful chemicals under certain conditions. This recall is classified as a correction rather than a full product withdrawal, impacting 8,186 units distributed between February 12, 2021, and July 24, 2024. The company informed customers in the U.S. through email and phone communications, revealing that internal tests of the Vivo 45 LS had detected the possibility of users experiencing temporary elevated formaldehyde levels under specific scenarios.

A representative from Breas told MD+DI, "The test conditions represent operation under certain conditions, beyond those expected to be encountered during actual operation of the device with patients. We are communicating with our customers to ensure that the correction is notified and no patient treatment is disrupted.”

According to the company's press release, brief exposure to formaldehyde emissions could cause negative effects on the lungs or nervous system, including temporary and reversible irritation or inflammation of the airways. In small pediatric patients, this could lead to airway hyperresponsiveness, such as asthma, requiring additional medical interventions. These interventions might include the use of bronchodilators, adjustments to ventilator settings, or an increase in the duration or level of ventilatory and oxygen support.

So far, Breas has not received any reports of patient injuries or adverse effects connected to this issue. The affected devices can be identified by checking the model name on the front panel and the model and serial numbers on the back panel. As part of the corrective measures, the company is informing distributors and commercial customers about updates to the device’s instructions for use (IFU). These updates include lowering the maximum operating room temperature from 104°F (40°C) to 86°F (30°C) and requiring that new devices shipped through July 24, 2024, be pre-run for 14 days before being used by patients.

Breas futher said in the correction announcement, “End users and other recipients of the Vivo 45 LS device in the US should contact the company that provided the device or Breas Medical for further information regarding the necessary corrective measures if needed.”