Boston Scientific Corporation recalls VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

Recall date

December 12, 2024

Source

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

Recall number

Z-0827-2025

FDA classification

Class I

Brand / firm

Boston Scientific Corporation

Sold / distributed

US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.

Why it was recalled

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

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

VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)