Model Number L100, ESSENTIO SR SL Pacemaker
Pending LLM rewrite. Source: FDA_DEVICE Z-0092-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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).
The recalled product
- Product
- Model Number L100, ESSENTIO SR SL Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00802526559150
- Serial Numbers: 464853
- 464855
- 464865
- 464866
- 464867
- 464868
- 464871
- 464872
- 464874
- 464879
- 464881
- 464882
- 464886
- 464896
- 464907
- 464911
- 464912
- 464913
- 464914
Distribution
Distribution scope not specified by the agency.
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