Model Number U128, VALITUDE CRT-P EL MRI — recall Z-0102-2026
U.S. FDA — Device Enforcement · United States · 2025-08-20 · Class I
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Reported risk: 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).
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