North Billerica, MA, United States
Breas Medical, Inc. recalls
5 recalls recorded since 2018, most recently on 25 July 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 25 July 2024
- Reason
- 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.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2690-2024
- 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 (2300
Ongoing Class II Medical devices
- Recall started
- 13 October 2023
- Reason
- Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
- Distribution
- Nationwide Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0405-2024
- with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to f
Ongoing Class II Medical devices
- Recall started
- 2 June 2022
- Reason
- A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1382-2022
- Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software,
Terminated Class II Medical devices
- Recall started
- 21 March 2022
- Terminated
- 13 December 2024
- Reason
- Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0943-2022
- Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Terminated Class II Medical devices
- Recall started
- 28 January 2020
- Terminated
- 15 September 2020
- Reason
- The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, FL, GA, IA, IL, KS, MA, MI, MO, NJ, NY, OH, PR, SC, TX, VA, WI and countries distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1352-2020
- Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional prot
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.