Recall Z-0827-2025— Boston Scientific Corporation

Name: FDA recall Z-0827-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-12

Class I · Ongoing

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2024-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228). Reason: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class I
Status: Ongoing
Initiated: 2024-12-12
Firm location: Saint Paul, MN, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.