On November 20, 2018, Abbott provided an Urgent Medical Device Correction notice to customers communicating a voluntary recall of a small number of Confirm Rx™ DM3500 Insertable Cardiac Monitors (ICM) subject to a communication issue resulting in the inability to pair the implanted device with the mobile phone app. Please find the below physician communication document for further information.
This document provides recall information for a small number (33 total devices) of Confirm Rx DM3500 Insertable Cardiac Monitors (ICM) in 2018.
We notified physicians that exposure to sub-freezing temperatures during our supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Insertable Cardiac Monitoring (ICM) Model DM3500 devices. Updated Merlin programmer software will be made available to allow physicians to detect the presence of an incorrect low battery indicator prior to implant and provide a mechanism to resolve the incorrect display for already implanted devices.
MAT-2010753 v1.0
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Precautions
Please be sure to read it.
The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
Are you a healthcare professional?
Test
