Model Number L110, ESSENTIO SR SL MRI Pacemaker
Pending LLM rewrite. Source: FDA_DEVICE Z-0094-2026.
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 L110, ESSENTIO SR SL MRI 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 00802526559204
- Serial Numbers: 102163
- 700197
- 700207
- 701035
- 701546
- 702086
- 702129
- 702195
- 702303
- 702316
- 702343
- 702530
- 702612
- 702615
- 702619
- 702715
- 702745
- 702802
- 702807
Distribution
Distribution scope not specified by the agency.
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