Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps

Published: 05/07/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals

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 in…

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