FDA-Device2025-10-22Class I
Model Number L101, ESSENTIO 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
22,714 units
Manufactured in
4100 Hamline Ave N, Saint Paul, MN, United States
Products
Model Number L101, ESSENTIO DR SL Pacemaker
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0093-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief