[pending] Model Number L231, PROPONENT DR EL MRI Pacemaker
Pending LLM rewrite. Source: FDA_DEVICE Z-0091-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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