WASHINGTON (dpa-AFX) - Breas Medical has recalled 8,186 Vivo 45 LS ventilator devices in the United States for correction, according to the U.S. Food and Drug Administration.
The national correction was initiated after internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions.
The devices subject to the correction were manufactured from February 4, 2021 to July 1, 2024, and distributed from February 12, 2021 to July 24, 2024. The devices have been distributed across the country to Durable Medical Equipment providers or DME's, distributors, and facilities.
According to the agency, short term formaldehyde emissions may lead to adverse pulmonary or neurological effects. These include 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. The required medical intervention may include bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support.
So far, 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.
Breas Medical's planned correction reduces the maximum room air temperature for operation of the device to 30°C (86°F) from 40°C (104°F) and requires new devices shipped through July 24, 2024, to be pre-run for 14 days prior to patient use.
Existing end users in the U.S. will receive an update to the Instructions for Use pr IFU as the correction.
End users and other recipients of the Vivo 45 LS device in the U.S. are asked to contact the company that provided the device or Breas Medical for further information regarding the necessary corrective measures if needed.
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