ACCOLADE DR EL MRI (Model L331)
Pending LLM rewrite. Source: FDA_DEVICE Z-0084-2026.
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
- ACCOLADE DR EL MRI (Model L331)
- 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 00802526559006
- Serial Numbers: 102138
- 102172
- 102192
- 102209
- 102210
- 102229
- 102231
- 102232
- 102233
- 102237
- 102239
- 102243
- 102255
- 102256
- 102261
- 102263
- 102265
- 102266
- 102267
Distribution
Distribution scope not specified by the agency.
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