Vivo 45 LS Ventilator Recall Issued Over Formaldehyde Exposure Risks

Breas Medical is recalling 8,186 Vivo 45 LS ventilators due to a risk that  users may be exposed to elevated levels of formaldehyde, which is a toxic chemical that could lead to dangerous neurological or pulmonary effects, potentially resulting in the need for additional medical treatment.

The U.S. Food and Drug Administration (FDA) announced the Breas Vivo 45 LS ventilator recall on August 9. The device is one of the smallest compact ventilators on the market and designed for adults and children over 11 pounds.

Formaldehyde is an industrial chemical used to make many construction and building materials, paper products and cosmetics. However, exposure to high levels of the chemical is known to cause cancer and other serious health problems when inhaled or absorbed through the skin. Short-term exposure to formaldehyde can cause eye irritation if inhaled or allergic reactions if it touches the skin, while longer exposure can result in lung damage, severe eye irritation, reproductive issues, asthma, allergy-related conditions and even cancer.

According to the FDA announcement, exposure to excess amounts of formaldehyde in the ventilator can lead to a multitude of adverse side effects, including airway irritation or inflammation that may lead to airway hyperresponsiveness, such as asthma. This may result in the need for additional medical interventions, such as administration of a bronchodilator, increased duration or degree of ventilation or oxygen support.

Breas Vivo 45 LS ventilators are used to treat a variety of respiratory conditions, providing critical breathing support for individuals who need the independence and mobility of the device’s compact design, which features a battery that can last over 24 hours.

The recalled ventilators were manufactured between February 4, 2021 and July 1, 2024, and distributed throughout the U.S. between February 12, 2024 and July 24, 2024 by Durable Medical Equipment providers, distributors and facilities.

Affected devices can be identified by the model name on the front panel of the device and the model and serial numbers on the back panel. Serial numbers range in scope from D*****, F*****, K*****, M*****, N01*** – N270030, where the asterisks denote a digit between 0 and 9. Manufacturing dates for the recalled products are up to and including “240530,” or May 30th, 2024.

Breas Medical initiated the recall on August 5, and will be contacting distributors and customers by email and phone. For the correction, customers will receive an update to the device’s Instructions for Use.

The company said that it has not received any reports of patient injuries as of yet, and recommended that ventilators be pre-run for 14 days prior to patient use.

U.S.-based recipients of the Vivo 45 LS ventilators should contact the company that provided the device or Breas Medical for further information regarding necessary corrective measures.

The company can be reached via telephone at 1-855-436-8724 Monday through Friday between 8:00 a.m. and 5:00 p.m. ET. The company can also be contacted via email at vivotechnicalsupport@breas.com.

Healthcare professionals and consumers can report adverse reactions or quality issues experienced with these devices to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.