ACCOLADE SR SL MRI (Model L310)
Pending LLM rewrite. Source: FDA_DEVICE Z-0081-2026.
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 SR SL MRI (Model L310)
- 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 00802526558948
- Serial Numbers: 701140
- 701954
- 702152
- 702176
- 702278
- 702560
- 702997
- 702998
- 703023
- 703075
- 703125
- 703128
- 703138
- 703169
- 703172
- 703201
- 703203
- 703251
- 703253
Distribution
Distribution scope not specified by the agency.
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