Model Number U228, VISIONIST CRT-P EL MRI
Pending LLM rewrite. Source: FDA_DEVICE Z-0105-2026.
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 U228, VISIONIST CRT-P EL MRI
- 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 00802526559471
- Serial numbers: 726570
- 728246
- 728341
- 728391
- 728414
- 728416
- 728463
- 728492
- 728880
- 732912
- 733290
- 733427
- 733464
- 733475
- 733541
- 733672
- 733700
- 733703
- 733748
Distribution
Distribution scope not specified by the agency.
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