Breas Medical Issues Voluntary U.S. Nationwide Urgent Medical Device Correction

SWEDEN—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 Feb. 4, 2021 to July 1, 2024, and distributed from Feb. 12, 2021 to July 24, 2024.

Breas Medical said it 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.

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 U.S. to durable medical equipment providers (DMEs), distributors and facilities.

Affected Product Information Table

• Model name: Vivo 45 LS (U.S. version)
• Model number: 230000
• UDI-DI: 07321822300004
• Serial Numbers/Manufacturing Dates: D *****, F *****, K *****, M *****, N01 *** – N270030 Manufacturing dates up to and including “240530” (May 30, 2024)

Breas Medical is notifying its distributors and commercial customers in the U.S. 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 U.S. will receive an update to the Instructions for Use (IFU) as the correction, Breas said.

End users and other recipients of the Vivo 45 LS device in the U.S. 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-Friday between the hours of 8 a.m. ET and 5 p.m. ET. You may also contact the company via email at [email protected].

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

• Complete and submit the report online: fda.gov/medwatch/report.htm
• Regular mail or fax: Download form fda.gov/MedWatch/getforms.htm 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 U.S. nationwide correction.