TGA-486443

active

Product defect correction / Implant hazard alert: ACCOLADE 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: 19 December 2024

Description

Boston Scientific have advised that subsets of ACCOLADE and VISIONIST pacemakers have an increased risk of permanently entering Safety Mode which has limited functionality.

Hazard

Boston Scientific have advised that subsets of ACCOLADE and VISIONIST pacemakers have an increased risk of permanently entering Safety Mode which has limited functionality.

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