Model Number U225 VISIONIST CRT-P EL
Pending LLM rewrite. Source: FDA_DEVICE Z-0103-2026.
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 U225 VISIONIST CRT-P EL
- 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 00802526559426
- Serial numbers: 709683
- 709711
- 709737
- 709778
- 709780
- 709789
- 709792
- 709794
- 709804
- 709815
- 709816
- 709827
- 709828
- 709829
- 709830
- 709831
- 709889
- 709907
- 709912
Distribution
Distribution scope not specified by the agency.
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