Breas Medical Initiates Vivo 45 LS Ventilator Correction

Breas Medical recently initiated a voluntary recall of its Vivo 45 LS ventilators after identifying the potential for elevated toxic chemical exposure under specific conditions. The recall is considered a correction, not product removal and affects 8,186 ventilators distributed from Feb. 12, 2021, to July 24, 2024.

The company notified customers in the US by email and phone that internal testing of Vivo 45 LS indicated the potential for short term elevated levels of formaldehyde exposure to users under specific circumstances.

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

Exposure to short term formaldehyde emissions could result in adverse pulmonary or neurological effects like the potential for transient, reversible airway irritation or inflammation that could lead to “airway hyperresponsiveness such as asthma in small pediatric patients resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support),” according to the company press release.

Currently, Breas has not received any reports of patient injury or adverse effects related to the correction.

Affected devices can be identified by the model name on the front panel of the product and the model and serial numbers on the back panel.

As part of the correction, the company is notifying distributors and commercial customers about updates to the device’s instructions for use (IFU). The changes to the IFU include reducing the maximum room air temperature for operation of the device from 104°F (40°C) to 86°F (30°C) and requiring new devices shipped through July 24, 2024, to be pre-run for 14 days prior to patient use.

“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,” Breas said in the correction announcement.

The company is still evaluating the root cause for the issue.

"Breas is continuing its evaluation, including identifying and eliminating the root cause of formaldehyde emissions," the company told MD+DI.