FDA-Device2025-10-22Class I
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific Corporation
Hazard
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).
Sold states
Worldwide
Affected count
4055 units
Manufactured in
4100 Hamline Ave N, Saint Paul, MN, United States
Products
Model Number S702, ALTRUA 2 DR SL Pacemaker
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2026Don't want to check this manually?
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