Breas Medical has issued a nationwide correction for Vivo 45 LS ventilators due to potential short-term formaldehyde exposure.

RT’s Three Key Takeaways:

1. Correction for Formaldehyde Risk: Breas Medical initiated a US nationwide correction for 8,186 Vivo 45 LS ventilators due to the potential for short-term elevated formaldehyde emissions, which may lead to respiratory issues, especially in small pediatric patients.
2. Updated Operating Conditions: The correction includes reducing the maximum room air temperature for operating the ventilators from 104°F to 86°F and requires that new devices be pre-run for 14 days prior to patient use.
3. No Reported Adverse Effects: To date, Breas Medical has not received any reports of patient injury or adverse effects related to the potential formaldehyde exposure from the affected devices, but users are encouraged to follow the updated instructions and contact Breas Medical for further guidance.

Breas Medical initiated a US nationwide correction of 8,186 Vivo 45 LS ventilator devices due to 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 (eg, 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 Feb 4, 2021, to July 1, 2024, and distributed from Feb 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.

Affected Devices

The devices in the table below are subject to this correction. The devices in the table can be identified by the model name on the front panel of the device and the model and serial numbers on the back panel (REF and SN, respectively). The devices have been distributed nationwide in the US to durable medical equipment providers, distributors, and facilities.

Updated Instructions for Use

Breas Medical is notifying its distributors and commercial customers in the US by email and phone of the correction. The correction reduces the maximum room air temperature for operation of the device from 40°C (104°F) to 30°C (86°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 US will receive an update to the instructions for use as the correction.

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.

Patients, caregivers, and other users of the Vivo 45 LS device with questions may contact the Breas Medical via telephone at 1-855-436-8724 Monday through Friday between 8 am and 5 pm (Eastern time zone) or contact the company via e-mail at [email protected].

Adverse reactions or quality problems experienced with the use of this product may be reported to the US Food and Drug Administration (FDA)’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Breas Medical has notified FDA of this voluntary US nationwide correction.

Photo caption: Vivo 45 LS

File photo