Model Number U226, VISIONIST CRT-P EL
Pending LLM rewrite. Source: FDA_DEVICE Z-0104-2026.
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 U226, 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 00802526559457
- Serial numbers: 700333
- 700335
- 700342
- 700344
- 700346
- 700347
- 700352
- 700364
- 700372
- 700386
- 700388
- 700390
- 700391
- 700425
- 700426
- 700427
- 700428
- 700429
- 700437
Distribution
Distribution scope not specified by the agency.
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