FDA-Device2025-10-22Class I
Model Number L100, ESSENTIO SR SL Pacemaker
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
4827 units
Manufactured in
4100 Hamline Ave N, Saint Paul, MN, United States
Products
Model Number L100, ESSENTIO SR SL Pacemaker
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2026More Boston Scientific Corporation recalls
- FDA-Device2026-09-09Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
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