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Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025

ACCOLADE SR SL MRI (Model L310)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025

PROPONENT DR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

ACCOLADE EL DR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

ACCOLADE SR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

ESSENTIO MRI SR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

ACCOLADE MRI SR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

ALTRUA 2 SR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

PROPONENT EL DR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

ACCOLADE DR SL (Model L301)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025

ACCOLADE DR EL MRI (Model L331)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025

Model Number L100, ESSENTIO SR SL Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025

ACCOLADE SR SL (Model L300)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025

Model Number L121 ESSENTIO DR EL Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025

PROPONENT MRI Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

ESSENTIO MRI EL DR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231*; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·March 19, 2026

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·June 3, 2021

ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 12, 2024

ACCOLADE DR Pacemaker

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017