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Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps
Boston Scientific has issued an Urgent Medical Device Correction to affected customers recommending all ACCOLADE pacemakers and CRT-Ps be upgraded to Brady SMR6 software. This includes Essentio, Proponent, Accolade, Altrua 2, Valitude, and Visionist devices.
Boston Scientific initiated this correction to expand the affected device scope to include all ACCOLADE CRT-P and DR-EL devices due to the potential that an individual device will need to be replaced early due to high battery impedance induced ZIP Telemetry disablement. This correction also implements Brady SMR6, a software/firmware update intended to address unintended behaviors with the Brady SMR5 software.
This recall involves correcting 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 without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Boston Scientific at tech.services@bsci.com or 1-800-227-3422.
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