USDA And Fedwatch Recall Alerts

Breas Medical Issues Voluntary U.S. Nationwide Urgent Medical Device Correction of Vivo 45 LS Ventilator

On August 5, 2024, Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects such as 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).

The devices subject to this correction were manufactured from February 4, 2021 to July 1, 2024, and distributed from February 12, 2021 to July 24, 2024.

Breas Medical has not received any reports of patient injury or adverse effects related to potential exposure to formaldehyde from the use of the Vivo 45 LS, to date.