Breas Medical has announced a nationwide correction of 8,186 Vivo 45 LS ventilator devices after internal testing determined that the product may be putting users at risk for exposure of short term heightened levels of formaldehyde, reports the FDA.
Those subjected to even short-term emissions of formaldehyde could suffer a range of “adverse pulmonary or neurological effects.” Such conditions may include temporary irritation or inflammation of the airway, causing a “hyperresponsiveness” like asthma in children, which could then necessitate a number of further medical interventions: administering a bronchodilator, adjusting the ventilator settings, prolonging the duration or ramping up the degree of ventilatory and/or oxygen support.
Initiated by Breas Medical on August 8, 2024, the correction impacts Vivo 45 LS ventilator devices that were manufactured between February 4, 2021 and July 1, 2024. Officials say the affected devices were distributed to Durable Medical Equipment (DME) providers, distributing partners, and facilities across the U.S. between February 12, 2021, and July 24, 2024.
While the company has not been made aware of any injuries or other adverse events in connection to a potential formaldehyde exposure brought on by use of the product, Breas Medical distributors and commercial customers in the U.S. were alerted to the correction via email and phone.
According to the product correction, the Vivo 45 LS device should not be operated in a room air temperature exceeding 30 degrees Celsius (86 degrees Fahrenheit)–a reduction from the previous maximum of 40 degrees Celsius (104 degrees Fahrenheit). Any new devices distributed past July 24, 2024, is also required to be pre-operated for 2 weeks (14 days) before it is used by a patient.
Officials say current end users within the U.S. will also be sent an updated set of Instructions for Use (IFU). For further information about the necessary corrective measures, all end users, and anyone else in the U.S. who may be in possession of the Vivo 45 LS device, is instructed to contact either the provider of the device or Breas Medical directly.
Breas Medical can be reached by phone at 1-855-436-8724. Calls are monitored Monday through Friday, from 8:00 a.m. to 5:00 p.m. Eastern Time. Emails can also be sent to vivotechnicalsupport@breas.com.
As the FDA continues to oversee this recall, anyone experiencing or witnessing adverse outcomes related to the device is urged to report the incident to the agency’s MedWatch program.
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