Medical Device Recall: Model Number L221 PROPONENT DR EL Pacemaker
Boston Scientific Corporation · August 20, 2025
Reason for Recall
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).
Distribution
Worldwide
Quantity Affected
3592 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0090-2026
Status: ongoing
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