Company: Boston Scientific Corporation
Date of Enforcement Report: 10/10/2025
Class: I
PRODUCT
ACCOLADE SR SL (Model L300)
Recall Number:
Z-0079-2026
REASON:
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
RECALLING FIRM/MANUFACTURER:
Boston Scientific Corporation
VOLUME:
16,077 units
DISTRIBUTION:
Worldwide
