ACCOLADE DR EL (Model L321)
Pending LLM rewrite. Source: FDA_DEVICE Z-0083-2026.
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 (Model L321)
- 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 00802526558986
- Serial Numbers: 100004
- 100005
- 100033
- 100051
- 100054
- 100058
- 100075
- 100076
- 100092
- 100106
- 100107
- 100109
- 100111
- 100115
- 100116
- 100117
- 100118
- 100119
- 100120
Distribution
Distribution scope not specified by the agency.
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