Model Number L131, ESSENTIO DR EL MRI Pacemaker
Pending LLM rewrite. Source: FDA_DEVICE Z-0097-2026.
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 L131, ESSENTIO DR EL 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 00802526559266
- Serial Numbers: 102068
- 102071
- 102072
- 102074
- 102086
- 102089
- 102091
- 102092
- 102094
- 102095
- 102097
- 102101
- 102102
- 102104
- 102108
- 102115
- 102120
- 102122
- 102124
Distribution
Distribution scope not specified by the agency.
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