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  5. Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators
  1. Medical Device Recalls

Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators

This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Photo of: Vivo 45 LS (U.S. version)

Affected Product

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

What to Do

Follow all updates and additions to the Vivo 45 LS Instructions for Use, which include:

  • Use Vivo 45 LS only at maximum room air temperature of 30°C (previously 40°C) or less.
  • Before patient use, “pre-run” all new devices (distributed on or before July 24, 2024) for at least 14 days in an ambient room temperature of at least 20°C (68°F) if they haven’t been used in the last 14 days.
    • Or instead of performing a pre-run, you can contact Breas Medical Service or the local Service Representative to receive a ready-to-use replacement Vivo 45LS. This will be a new, unused device that has already been pre-run for 14 days prior to shipment.

On August 5, 2024, Breas Medical sent all affected customers an Urgent Medical Device Correction recommending the following additional actions:

Actions for Customers/Users

  • Operate the device at a maximum room air temperature of 30°C (previously 40°C) because elevated formaldehyde levels were observed when Vivo 45 LS was operated at higher room temperatures.
  • “Pre-run” any Vivo 45 LS devices distributed on or before July 24, 2024, that are new or have not been in use within the last two weeks for at least 14 days in an ambient room temperature of at least 20°C (68°F).
    • Perform the pre-run 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.
    • Place devices being pre-run in a dedicated, well-ventilated room.
    • Minimize time when personnel are working with the devices during pre-run. People should be in the room only intermittently to connect and setup or disconnect devices.
    • An air purifier containing an activated charcoal filter may be placed in the room.
  • Instead of performing a pre-run you can contact Breas Medical Service or the local Service Representative to receive a ready-to-use replacement Vivo 45LS. This will be a new, unused device that has already been pre-run for 14 days prior to shipment.
  • Make sure all potential users in the facility are aware of this safety notification and the recommended actions.
  • Retain the notification as an addendum to the Instructions for Use and for records.
  • Keep a copy of this document available with the Instructions for Use.
  • Complete and return the acknowledgement form attached to the letter to vivotechnicalsupport@breas.com.

Reason for Recall

Breas Medical is updating use instructions for Vivo 45 LS ventilators after internal testing of the ventilator identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time.

The use of affected product and short-term exposure to formaldehyde emissions may cause serious adverse health consequences, especially in small pediatric patients, that include temporary, reversible airway irritation or inflammation leading to airway issues such as asthma, and death.

There have been no reported injuries. There have been no reports of death.

Device Use

The Vivo 45 LS ventilator is intended to provide continuous or intermittent ventilatory support for people who require mechanical ventilation to support their breathing. The ventilator is used for pediatric patients weighing more than 5kg through adults (mouthpiece ventilation for adults only). Vivo 45 LS ventilators are used in homes and health care settings as well as serving as portable ventilators for wheelchairs and gurneys.

Contact Information

Customers in the U.S. with questions about this recall should contact their local service representative or Breas Medical Inc. service at 855-436-8724 ext. 110 or e-mail vivotechnicalsupport@breas.com.

Additional FDA Resources

Additional Company Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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