Model Number L231, PROPONENT DR EL MRI Pacemaker
Pending LLM rewrite. Source: FDA_DEVICE Z-0091-2026.
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 L231, PROPONENT 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 00802526559143
- Serial Numbers: 756161
- 799038
- 841168. GTIN 00802526576423
- Serial Numbers: 532638
- 880141
- 973836. GTIN 00802526578052
- Serial Numbers: 594082
- 727921
- 812172
- 832267
- 899037
- 944246
- 978524. GTIN 00802526559143
- Serial Numbers: 100008
- 100026
- 100030
- 100038
- 100045
- 100046
Distribution
Distribution scope not specified by the agency.
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