TGA-514853

active

ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)

Category: Medicine · Supplier: Unknown

Recall date: 10 September 2025

Description

Product correction and Product alert. This update includes new information regarding the software correction, actions for healthcare professionals and inclusion of the single chamber (SR) pacemaker.

Hazard

Product correction and Product alert. This update includes new information regarding the software correction, actions for healthcare professionals and inclusion of the single chamber (SR) pacemaker.

Source: https://www.tga.gov.au/safety/recalls-and-other-market-actions/market-actions/accolade-single-chamber-sr-dual-chamber-dr-standard-life-sl-and-dr-extended-life-el-pacemakers-and-visionist-cardiac-resynchronization-therapy-pacemakers-crt-ps