FDA recall Z-0826-2025

Product

VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-12-12

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2025