Model Number U128, VALITUDE CRT-P EL MRI
Pending LLM rewrite. Source: FDA_DEVICE Z-0102-2026.
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 U128, VALITUDE 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 00802526559402
- Serial numbers: 100187
- 100217
- 100222
- 100236
- 100251
- 100253
- 100260
- 100262
- 100274
- 100275
- 100277
- 100289
- 100317
- 100328
- 100330
- 100350
- 100359
- 100361
- 100363
Distribution
Distribution scope not specified by the agency.
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