The FDA has classified the recall as its most serious, warning that continued use without intervention could result in serious injury or death, according to a Feb. 21 agency news release.
The recall affects several pacemaker models: Accolade, Proponent, Essentio, Altrua 2, Visionist and Valitude. Boston Scientific has advised healthcare providers to monitor affected patients closely and to schedule device replacements when necessary.
A total of 832 injuries and two deaths related to the device have been reported, the release said.
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