Vivo 45 LS, pressure and volume ventilator capable of del... (Breas Medical, Inc.) – there is a potential for short term (... (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Brand
Breas Medical, Inc.
Lot Codes / Batch Numbers
Model No 230000, UDI-DI 07321822300004, Lot Code: all lots up to 240530.
Products Sold
Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.
Breas Medical, Inc. is recalling Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilat due to There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Recommended Action
Per FDA guidance
On August 5, 2024, URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions to be taken by Customer / User: 1. Since the elevated levels of formaldehyde were observed with the Vivo 45 LS operated at higher room temperatures, 40C (104F), as a matter of precaution, Breas Medical is lowering the maximum room air temperature for operation of the device from 40C (104F) to 30C (86F). 2. The following additional measure applies to new Vivo 45 LS devices distributed on or before July 24, 2024, that have not been in use for at least 14 days: Pre-run the device for at least 14 days in an ambient room temperature of at least 20C (68F). The pre-run can be performed in any ventilation treatment mode (for example: CPAP at 4 cmH2O). Make sure that the device s air outlet is not blocked, so that the air flows out from the device. Devices being pre-run should be in a dedicated, well-ventilated room. Personnel working with the devices should be in the room only intermittently, for time needed to connect and setup or disconnect devices. 3. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 4. Retain this document as an addendum to the Instructions for Use and for your records. Please keep a copy of this document available with the Instructions for Use. 5. Complete and return the attached acknowledgement form to vivotechnicalsupport@breas.com and inga.dolezar@breas.com (You only need to send one acknowledgement form.) Contact Information: If you have any questions or concerns regarding this notification, please contact Breas Medical Inc. service or your local Service Representative. Breas Medical Inc. service can be reached at 855-436-8724 ext. 110 between 8.00am and 5.00pm ET Mondays through Fridays, or by e-mail vivotechnicalsupport@breas.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026