Boston Scientific Corporation recalls Model Number U128, VALITUDE CRT-P EL MRI

Recall date

August 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0102-2026

FDA classification

Class I

Brand / firm

Boston Scientific Corporation

Sold / distributed

Worldwide

Why it was recalled

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).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Model Number U128, VALITUDE CRT-P EL MRI