There have been 29 complaints, including 19 serious injuries and two deaths, related to the device issue.
The number of recalls also increased 21.5% this quarter, according to Stericycle’s Q3 2019 Recall Index.
FDA has released a MedWatch Safety Alert about an issue with the LifeVest that can lead to a failure to deliver treatment.
An electrical test failure code could cause the device to fail to initiate therapy.
A potential defect could cause the auto-injectors to fail to activate in an emergency.