Model Number L210 PROPONENT SR SL Pacemaker
Pending LLM rewrite. Source: FDA_DEVICE Z-0088-2026.
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 L210 PROPONENT SR SL 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 00802526559082
- Serial Numbers: 100002
- 100009
- 100010
- 100011
- 100012
- 100014
- 100017
- 100020
- 100021
- 100023
- 100024
- 100026
- 100029
- 100034
- 100037
- 100038
- 100040
- 100041
- 100045
Distribution
Distribution scope not specified by the agency.
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